Spinal Fusion Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Spinal Fusion Pipeline Market Report Overview

Spinal Fusion procedures are mainly performed on the cervical and thoracolumbar regions. Spinal fusion is a surgical procedure that involves joining two vertebrae in the spine to form a single solid bone, with the involvement of certain devices, to relieve pain. Conventional and Minimally Invasive Surgery (MIS) methods are used to perform Spinal Fusion. Conventional methods include all open surgical methods that are used for performing spinal procedures.

The Spinal Fusion pipeline market research report provides comprehensive information about the Spinal Fusion pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials that are in progress.

Key Segments ·        Interbody Devices

·        Pedicle Screw Systems

·        PEEK Interbody Devices

·        Spinal Plating Systems

·        Metal Interbody Devices

·        Cervical Spinal Plating Systems

Key Territories ·        The United States

·        Europe

·        China

·        United Kingdom

·        Australia

·        India

·        Israel

·        Taiwan

Key Regulatory Paths ·        510(k)

·        CE

·        NMPA

·        PMA

·        UKCA

·        TGA

·        ICAC

·        BOPA

Leading Companies ·        Acuitive Technologies Inc

·        Allegra Medical Technologies Ltd

·        ALM Ortho Inc

·        Alphatec Holdings Inc

·        AMB Surgical II LLC

·        APTO Orthopaedics

·        Aurora Spine Corp

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Spinal Fusion Pipeline Market Segmentation by Territories

A few of the key territories in the Spinal Fusion market are the US, Europe, China, the United Kingdom, Australia, India, Israel, and Taiwan among others. As of February 2024, the US accounts for the highest number of pipeline products in the Spinal Fusion Pipeline industry.

Spinal Fusion Pipeline Market Analysis by Territories, 2024 (%)

Spinal Fusion Pipeline Market Analysis by Territories, 2024 (%)

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Spinal Fusion Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths in the Spinal Fusion pipeline market are 510(K), CE, NMPA, PMA, UKCA, TGA, ICAC, and BOPA. As of February 2024, 510(K) is the most followed pathway for pipeline products in the Spinal Fusion Pipeline market.

Spinal Fusion Pipeline Market Analysis by Regulatory Paths, 2024 (%)

Spinal Fusion Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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Spinal Fusion Pipeline Market – Competitive Landscape

A few of the major players in the Spinal Fusion pipeline market are Acuitive Technologies Inc., Allegra Medical Technologies Ltd, ALM Ortho Inc., Alphatec Holdings Inc, AMB Surgical II LLC, APTO Orthopaedics, and Aurora Spine Corp among others.

Allegra Medical Technologies Ltd (Allegra): Allegra Medical Technologies Ltd (Allegra), develops, manufactures, and sells prosthetic implants. Its products include adult and adolescent clavicle fixation system and pin, shoulder implants, proximal humeral plates, and trauma distal radial plates among others. It offers manufacturing services such as instrument manufacturing and precision manufacturing to other companies. The company’s operations are predominantly in Australia. Allegra is headquartered in Lane Cove West, New South Wales, Australia.

Spinal Fusion Pipeline Market Analysis by Companies, 2024

Spinal Fusion Pipeline Market Analysis by Companies, 2024

Buy the Full Report for More Company Insights into the Spinal Fusion Pipeline Market

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Segments Covered in the Report

Spinal Fusion Pipeline Market Segments Outlook

  • Interbody Devices
  • Pedicle Screw Systems
  • PEEK Interbody Devices
  • Spinal Plating Systems
  • Metal Interbody Devices
  • Cervical Spinal Plating Systems

Spinal Fusion Pipeline Market Territories Outlook

  • The United States
  • Europe
  • China
  • United Kingdom
  • Australia
  • India
  • Israel
  • Taiwan

Spinal Fusion Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • CE
  • NMPA
  • PMA
  • UKCA
  • TGA
  • ICAC
  • BOPA

Scope

  • The report provides extensive coverage of the Spinal Fusion under development.
  • The report reviews details of major pipeline products which include, product description, licensing and collaboration details, and other developmental activities.
  • The report reviews the major players involved in the development of Spinal Fusion and lists all their pipeline projects.
  • The coverage of pipeline products is based on various stages of development ranging from Early Development to Approved / Issued stage.
  • The report provides key clinical trial data of ongoing trials specific to pipeline products.
  • Furthermore, the report entails the recent developments in the segment/industry.

Reasons to Buy

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies.
  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain competitive advantage.
  • Identify and understand important and diverse types of Spinal Fusion under development.
  • Develop market-entry and market-expansion strategies.
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.
  • In-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Acuitive Technologies Inc
Allegra Medical Technologies Ltd
ALM Ortho Inc
Alphatec Holdings Inc
AMB Surgical II LLC
APTO Orthopaedics
Aurora Spine Corp
Biedermann Motech GmbH & Co KG
Bio2 Technologies Inc
Bioretec Ltd
Butterfly Spine, LLC
Camber Spine Technologies LLC
Carlsmed Inc
Choice Spine LLC
Clariance Inc
Clariance SAS
Corelink LLC
Cortical Concepts (Inactive)
CTL Amedica Corp
Curiteva Inc
Cutting Edge Spine LLC
DePuy Synthes Inc
DSM Biomedical BV
DSM Dyneema BV
Eden Spine LLC (Inactive)
EDGe Surgical Inc
EIT Emerging Implant Technologies GmbH
Eminent Spine LLC
ErgoSpine
Evoke Medical LLC
FacetMed Ltd
Fuse Medical Inc
GS Medical LLC
H. Lee Moffitt Cancer Center & Research Institute Inc
HAPPE Spine LLC
HD LifeSciences LLC
Hospital for Special Surgery
Implanet SA
Inion Oy
Innospina LLC
Intelligent Implant Systems LLC
Intelligent Implants
Jemo Spine, LLC.
joimax GmbH
LESspine LLC
Lifespans Ltd
Maxigen Biotech Inc
Mayo Clinic
Medicrea Group
Medos International Sarl
Medtronic Plc
Medyssey Co Ltd
Mekanika Inc
Mercy Health Research
Mesoblast Ltd
MI4 Spine, LLC
Michigan State University
MicroPort Scientific Corp
N8 Medical LLC
Nanovis Inc
Nasseo, Inc.
NEOS Surgery SL
Neumedix Surgical Pty Ltd
Nexilis AG
Nexxt Spine LLC
Novadip Biosciences SA
Novum Medical Products, Inc.
Nutech Medical Inc
NuVasive Inc
Orchid Orthopedic Solutions LLC
Orthobond
Osseus Fusion Systems LLC
OsteoGeneX Inc
OsteoVantage Inc
Ozop Surgical Corp (Inactive)
Pharmaco-Kinesis Corp
Providence Medical Technology Inc
RegeneEx Ltd.
Resoimplant GmbH (Inactive)
RevBio Inc
ReVivo Medical, LLC
Sail Fusion LLC
SANUWAVE Health Inc
SeaSpine, Inc.
Signus Medical LLC
SINTX Technologies Inc
Spinal Balance Inc.
Spinal Elements Inc
Spinal Resources Inc
Spinal Simplicity LLC
SpinalVu Inc (Inactive)
Spine Wave Inc
SpineGuard SA
SpineSmith Holdings LLC
SpineVision SA
Sree Chitra Tirunal Institute for Medical Sciences & Technology
Stryker Corp
Taragenyx Ltd (Inactive)
Theradaptive Inc
Tissue Regeneration Systems, Inc.
TranS1 Inc
TruSpine Technologies Plc
University of Colorado
University of Colorado Anschutz Medical Campus
University of Pittsburgh
University of South Florida
University of Toledo
University of Utah
University of Virginia
VersaSpine LLC
Vertech Inc
Verticor (Inactive)
VGI Medical LLC
Vivonics Inc
White Light Medical
Xtremity & Spinal Solutions Ltd
Yunyi (Beijing) Medical Device Co Ltd
Zyga Technology Inc
ZygoFix Ltd

Table of Contents

1 Table of Contents 3

1.1 List of Tables 15

1.2 List of Figures 26

2 Introduction 27

2.1 Spinal Fusion Overview 27

3 Products under Development 28

3.1 Spinal Fusion – Pipeline Products by Stage of Development 28

3.2 Spinal Fusion – Pipeline Products by Segment 29

3.3 Spinal Fusion – Pipeline Products by Territory 30

3.4 Spinal Fusion – Pipeline Products by Regulatory Path 31

3.5 Spinal Fusion – Pipeline Products by Estimated Approval Date 32

3.6 Spinal Fusion – Ongoing Clinical Trials 33

4 Spinal Fusion – Pipeline Products under Development by Companies 34

4.1 Spinal Fusion Companies – Pipeline Products by Stage of Development 34

4.2 Spinal Fusion – Pipeline Products by Stage of Development 39

5 Spinal Fusion Companies and Product Overview 44

5.1 Acuitive Technologies Inc Company Overview 44

5.1.1 Acuitive Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.2 Allegra Medical Technologies Ltd Company Overview 45

5.2.1 Allegra Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 45

5.3 ALM Ortho Inc Company Overview 46

5.3.1 ALM Ortho Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.4 Alphatec Holdings Inc Company Overview 48

5.4.1 Alphatec Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 48

5.5 AMB Surgical II LLC Company Overview 53

5.5.1 AMB Surgical II LLC Pipeline Products & Ongoing Clinical Trials Overview 53

5.6 APTO Orthopaedics Company Overview 54

5.6.1 APTO Orthopaedics Pipeline Products & Ongoing Clinical Trials Overview 54

5.7 Aurora Spine Corp Company Overview 55

5.7.1 Aurora Spine Corp Pipeline Products & Ongoing Clinical Trials Overview 55

5.8 Biedermann Motech GmbH & Co KG Company Overview 58

5.8.1 Biedermann Motech GmbH & Co KG Pipeline Products & Ongoing Clinical Trials Overview 58

5.9 Bio2 Technologies Inc Company Overview 59

5.9.1 Bio2 Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 59

5.10 Bioretec Ltd Company Overview 61

5.10.1 Bioretec Ltd Pipeline Products & Ongoing Clinical Trials Overview 61

5.11 Butterfly Spine, LLC Company Overview 63

5.11.1 Butterfly Spine, LLC Pipeline Products & Ongoing Clinical Trials Overview 63

5.12 Camber Spine Technologies LLC Company Overview 62

5.13 Carlsmed Inc Company Overview 65

5.14 Choice Spine LLC Company Overview 66

5.15 Clariance Inc Company Overview 68

5.16 Clariance SAS Company Overview 69

5.17 Corelink LLC Company Overview 72

5.18 Cortical Concepts (Inactive) Company Overview 75

5.19 CTL Amedica Corp Company Overview 76

5.20 Curiteva Inc Company Overview 77

5.21 Cutting Edge Spine LLC Company Overview 80

5.22 DePuy Synthes Inc Company Overview 82

5.23 DSM Biomedical BV Company Overview 84

5.24 DSM Dyneema BV Company Overview 87

5.25 Eden Spine LLC (Inactive) Company Overview 88

5.26 EDGe Surgical Inc Company Overview 89

5.27 EIT Emerging Implant Technologies GmbH Company Overview 90

5.28 Eminent Spine LLC Company Overview 91

5.29 ErgoSpine Company Overview 94

5.30 Evoke Medical LLC Company Overview 95

5.31 FacetMed Ltd Company Overview 96

5.32 Fuse Medical Inc Company Overview 98

5.33 GS Medical LLC Company Overview 100

5.34 H. Lee Moffitt Cancer Center & Research Institute Inc Company Overview 103

5.35 HAPPE Spine LLC Company Overview 105

5.36 HD LifeSciences LLC Company Overview 107

5.37 Hospital for Special Surgery Company Overview 108

5.38 Implanet SA Company Overview 109

5.39 Inion Oy Company Overview 115

5.40 Innospina LLC Company Overview 116

5.41 Intelligent Implant Systems LLC Company Overview 117

5.42 Intelligent Implants Company Overview 119

5.43 Jemo Spine, LLC. Company Overview 120

5.44 joimax GmbH Company Overview 122

5.45 LESspine LLC Company Overview 123

5.46 Lifespans Ltd Company Overview 127

5.47 Maxigen Biotech Inc Company Overview 128

5.48 Mayo Clinic Company Overview 129

5.49 Medicrea Group Company Overview 130

5.50 Medos International Sarl Company Overview 131

5.51 Medtronic Plc Company Overview 132

5.52 Medyssey Co Ltd Company Overview 135

5.53 Mekanika Inc Company Overview 136

5.54 Mercy Health Research Company Overview 137

5.55 Mesoblast Ltd Company Overview 138

5.56 MI4 Spine, LLC Company Overview 139

5.57 Michigan State University Company Overview 142

5.58 MicroPort Scientific Corp Company Overview 143

5.59 N8 Medical LLC Company Overview 145

5.60 Nanovis Inc Company Overview 146

5.61 Nasseo, Inc. Company Overview 147

5.62 NEOS Surgery SL Company Overview 148

5.63 Neumedix Surgical Pty Ltd Company Overview 149

5.64 Nexilis AG Company Overview 150

5.65 Nexxt Spine LLC Company Overview 151

5.66 Novadip Biosciences SA Company Overview 153

5.67 Novum Medical Products, Inc. Company Overview 154

5.68 Nutech Medical Inc Company Overview 156

5.69 NuVasive Inc Company Overview 157

5.70 Orchid Orthopedic Solutions LLC Company Overview 159

5.71 Orthobond Company Overview 160

5.72 Osseus Fusion Systems LLC Company Overview 161

5.73 OsteoGeneX Inc Company Overview 163

5.74 OsteoVantage Inc Company Overview 164

5.75 Ozop Surgical Corp (Inactive) Company Overview 165

5.76 Pharmaco-Kinesis Corp Company Overview 166

5.77 Providence Medical Technology Inc Company Overview 167

5.78 RegeneEx Ltd. Company Overview 170

5.79 Resoimplant GmbH (Inactive) Company Overview 171

5.80 RevBio Inc Company Overview 172

5.81 ReVivo Medical, LLC Company Overview 173

5.82 Sail Fusion LLC Company Overview 174

5.83 SANUWAVE Health Inc Company Overview 177

5.84 SeaSpine, Inc. Company Overview 178

5.85 Signus Medical LLC Company Overview 179

5.86 SINTX Technologies Inc Company Overview 180

5.87 Spinal Balance Inc. Company Overview 183

5.88 Spinal Elements Inc Company Overview 185

5.89 Spinal Resources Inc Company Overview 186

5.90 Spinal Simplicity LLC Company Overview 189

5.91 SpinalVu Inc (Inactive) Company Overview 190

5.92 Spine Wave Inc Company Overview 192

5.93 SpineGuard SA Company Overview 193

5.94 SpineSmith Holdings LLC Company Overview 194

5.95 SpineVision SA Company Overview 197

5.96 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 198

5.97 Stryker Corp Company Overview 199

5.98 Taragenyx Ltd (Inactive) Company Overview 202

5.99 Theradaptive Inc Company Overview 203

5.100 Tissue Regeneration Systems, Inc. Company Overview 206

5.101 TranS1 Inc Company Overview 207

5.102 TruSpine Technologies Plc Company Overview 208

5.103 University of Colorado Company Overview 211

5.104 University of Colorado Anschutz Medical Campus Company Overview 212

5.105 University of Pittsburgh Company Overview 213

5.106 University of South Florida Company Overview 214

5.107 University of Toledo Company Overview 219

5.108 University of Utah Company Overview 227

5.109 University of Virginia Company Overview 228

5.110 VersaSpine LLC Company Overview 229

5.111 Vertech Inc Company Overview 230

5.112 Verticor (Inactive) Company Overview 231

5.113 VGI Medical LLC Company Overview 232

5.114 Vivonics Inc Company Overview 233

5.115 White Light Medical Company Overview 234

5.116 Xtremity & Spinal Solutions Ltd Company Overview 235

5.117 Yunyi (Beijing) Medical Device Co Ltd Company Overview 237

5.118 Zyga Technology Inc Company Overview 238

5.119 ZygoFix Ltd Company Overview 239

6 Spinal Fusion – Recent Developments 244

6.1 Feb 22, 2024: Medacta International Receives Additional 510(K) Clearance for M.U.S.T. Pedicle Screw System – Extension 244

6.2 Feb 21, 2024: Orthofix Schedules Fourth Quarter and Full Year 2023 Earnings Release and Conference Call for March 5, 2024 244

6.3 Feb 21, 2024: joimax Expands Distribution in Italy – Announces New Partnership with Uber Ros S.p.A 244

6.4 Feb 20, 2024: MCRA Assists Curiteva with FDA 510(k) Clearance for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System 245

6.5 Feb 13, 2024: Innosys Receives 510(K) Clearance For INNOVERSE Spinal System 245

6.6 Feb 12, 2024: Smith+Nephew to Attend AAOS 2024 Annual Meeting 245

6.7 Feb 08, 2024: SI-Bone Received 510(K) Clearance For iFuse Bedrock Granite Implant System 246

6.8 Feb 06, 2024: icotec Medical Appoints Christoph Eigenmann as New US CEO and Promotes Carter Lonsberry to Executive Chairman of the Board 246

6.9 Feb 05, 2024: CTL Amedica Receives 510(K) Clearance For MONDRIAN Anterior Lumbar Plate System 247

6.10 Feb 05, 2024: Restor3d Receives Additional FDA 510(k) Clearance for TiDAL Lumbar Interbody Fusion Device 247

6.11 Feb 05, 2024: Globus Medical Receives 510(k) Clearance for ADIRA Lateral Plate System 247

6.12 Feb 05, 2024: Aurora Spine’s Second Patent Related to DEXA Technology Patient-Matched Implant Technology Issued by the United States Patent Office 247

6.13 Feb 01, 2024: U.S. FDA Grants Theradaptive IDE Approval for Phase I/II Clinical Trials 248

6.14 Jan 31, 2024: Stryker Corp Reports Strong Q4 and Full Year 2023 Results; Forecasts Continued Growth 249

6.15 Jan 30, 2024: SI-BONE Receives FDA 510(k) Clearance for a Smaller Diameter iFuse Bedrock Granite Implant with an Expanded Indication and Application 249

6.16 Jan 29, 2024: Spinal Simplicity Received Additional 510(K) Clearance For Minuteman G5 MIS Fusion Plate 250

6.17 Jan 29, 2024: Curiteva Receives FDA 510(k) Clearance for Curiteva Porous PEEK Lumbar Interbody Fusion System 250

6.18 Jan 26, 2024: NGMedical Receives FDA 510(k) Clearance for BEE HA Cervical Cage 250

6.19 Jan 22, 2024: Inspire(R) 3D Printed Trabecular PEEK(TM) With HAFUSE(R) Lumbar Interbody System Cleared by FDA 250

6.20 Jan 18, 2024: Aurora Spine Announces Attendance at North American Neuromodulation Society (NANS) Annual Meeting 251

6.21 Jan 15, 2024: IMPLANET Reports 2023 Annual Revenue of €7.4 Million 251

6.22 Jan 10, 2024: Providence Medical Technology Announces FDA Clearance of CAVUX FFS-LX Lumbar Facet Fixation System for 1- And 2-Level Lumbar Spinal Fusion 252

6.23 Jan 10, 2024: BioSenic Appoints Dr Carole Nicco as Chief Operating Officer in Addition to Chief Scientific Officer 253

6.24 Jan 09, 2024: Zavation Introduces 2-Screw ALIF Plating System–Z-Span 254

6.25 Jan 09, 2024: Orthofix Medical Announces Preliminary 2023 Fourth Quarter and Full-Year Net Sales Results 254

6.26 Jan 08, 2024: Compelling Clinical Data Released for Carlsmed’s aprevo Technology 255

6.27 Jan 04, 2024: Providence Medical Technology Receives 510(k) Clearance for PMT Facet Fixation System (PMT FFS-LX) 255

6.28 Jan 04, 2024: GBS Commonwealth Obtains Additional 510(k) Clearance for Peridot-PT Anterior Cervical Intervertebral Body Fusion System 256

6.29 Jan 04, 2024: GBS Commonwealth obtains Additional 510(K) Clearance For Peridot-PT Intervertebral Body Fusion System 256

6.30 Jan 04, 2024: GBS Commonwealth Receives Additional 510(K) Clearance For Peridot-TD Anterior Cervical Intervertebral Body Fusion System 256

6.31 Jan 04, 2024: GBS Commonwealth Receives Additional 510(K) Clearance For Peridot-TD Intervertebral Body Fusion System 257

6.32 Dec 30, 2023: Huvexel Receives Additional 510(k) Clearance for FaSet Fixation System 257

6.33 Dec 26, 2023: Shanghai Sanyou Medical Receives Additional 510(k) Clearance for Halis Lumbar Cage System 257

6.34 Dec 26, 2023: Huvexel Receives an Additional 510(K) Clearance For UNITY Sacroiliac Joint Fixation System 257

6.35 Dec 24, 2023: Medacta International Receives 510(k) Clearance for MySpine Cervical 257

6.36 Dec 21, 2023: Life Spine Secures Federal Court Order Permanently Prohibiting Marketing or Sale of AccelFix-XT Devices in the United States 258

6.37 Dec 20, 2023: Zavation Receives Additional FDA (510k) Clearance For Oro Lateral Plate System 258

6.38 Dec 20, 2023: JM Longyear Manufacturing Received Additional 510(k) Clearance for Valkyrie Thoracic Fixation System 258

6.39 Dec 20, 2023: Ulrich Medical USA Announces FDA Clearance for Expanded Indications of Momentum and Momentum MIS Systems 258

6.40 Dec 20, 2023: Tenon Medical Announces Participation in Two Key Immersive Webinar Physician Training Programs Featuring the Company’s Catamaran SI Joint Fusion System 259

6.41 Dec 19, 2023: SeaSpine Orthopedics Receives 510(K) Clearance For Shoreline Cervical Interbody RT System 259

6.42 Dec 19, 2023: Shanghai Reach Medical Instrument Receives FDA 510(k) Clearance For Expandable Lumbar Fusion Cage 260

6.43 Dec 19, 2023: Life Spine Receives FDA 510(k) Clearance for TruLift Micro Expandable Spacer System 260

6.44 Dec 19, 2023: Acuity Surgical Devices Receives FDA 510(k) Clearance for Align Cervical Interbody Fusion System 260

6.45 Dec 18, 2023: K&J Consulting Receives 510(K) Clearance For Statera-C Spinal System 260

6.46 Dec 12, 2023: Orthofix Announces Agreement with Engine Capital and Appointment of Three New Independent Directors to Further Advance Position as Leading Global Spine and Orthopedics Company 260

6.47 Dec 11, 2023: SeaSpine Receives Additional 510(K) Clearance For Shoreline ACS Anterior Cervical Standalone System 261

6.48 Dec 11, 2023: Spinal Simplicity Receives Additional 510(K) Clearance For Minuteman G5 MIS Fusion Plate 261

6.49 Dec 08, 2023: Double Medical Technology Receives 510(K) Clearance For Posterior Cervical Spine System 262

6.50 Dec 07, 2023: Accelus Announces Renewed Focus on Pioneering Minimally Invasive Outpatient Procedures with Its Advanced Adaptive Geometry Technology 262

6.51 Dec 07, 2023: Providence Medical Technology Announces New Publication Demonstrating High Fusion Rates and Successful Outcomes in Previously Failed Cervical Fusion Patients 263

6.52 Dec 06, 2023: Premia Spine Receives 510(K) Clearance For ProMIS Extension Rod System 264

6.53 Dec 06, 2023: Spinal Analytics & Geometrical Implant Receives 510(K) Clearance For TotalTi ACDF 264

6.54 Dec 05, 2023: Spinal Cage FDA Submission Update 264

6.55 Dec 04, 2023: Aurora Spine Announces Newly Published Paper on First 6-Month Clinical Evaluation of Its ZIP Fusion Implant 264

6.56 Nov 29, 2023: Astura Medical 265

6.57 Nov 29, 2023: CTL Amedica’s Monet ACIF Approved for Use in Mexico 265

6.58 Nov 28, 2023: Spinal Elements Announces Full Commercial Release of Ventana 3D-Printed Interbody Portfolio 266

6.59 Nov 28, 2023: Spinal Elements Announces Full Commercial Release of Ventana 3D-Printed Interbody Portfolio 267

6.60 Nov 24, 2023: SPINEWAY : International rollout of the VEOS implant range – First implants in Spain – New approvals in Colombia and Indonesia 267

6.61 Nov 21, 2023: GBS Commonwealth Receives Additional 510(K) Clearance For Peridot-PT Anterior Cervical Intervertebral Body Fusion System 268

6.62 Nov 21, 2023: GBS Commonwealth Receives Additional 510(K) Clearance For Peridot-PT Intervertebral Body Fusion System 268

6.63 Nov 15, 2023: Vy Spine scores FDA clearance for spinal fusion device 268

6.64 Nov 15, 2023: Spineology Receives Additional 510(K) Clearance For OptiMesh Multiplanar Expandable Interbody Fusion System 269

6.65 Nov 15, 2023: Globus Medical Receives 510(K) Clearance For VICTORY Lumbar Plate System 269

6.66 Nov 13, 2023: Aurora Spine Schedules Conference Call to Update Investors and Discuss Third Quarter Fiscal Year 2023 Financial Results 269

6.67 Nov 10, 2023: MiRus Receives 510(K) Clearance For RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System 270

6.68 Nov 10, 2023: Nexus Spine Receives Additional 510(K) Clearance For PressON Spinal Fixation System 270

6.69 Nov 10, 2023: Dio Medical Receives Additional 510(K) Clearance For Rexious Spinal Fixation System 270

6.70 Nov 09, 2023: K&J Consulting Receives 510(K) Clearance For Statera-M Spinal System 270

6.71 Nov 09, 2023: K&J Consulting Receives 510(K) Clearance For Statera Spinal System 271

6.72 Nov 09, 2023: SAGICO USA Receives 510(K) Clearance For Ripley Spinal Screw System 271

6.73 Nov 09, 2023: Xtant Medical Announces Record Third Quarter Revenue of $25 Million 271

6.74 Nov 08, 2023: Orthofix Reports Third Quarter 2023 Results 272

6.75 Nov 07, 2023: Orthofix Medical commercially launches WaveFormL system in US 273

6.76 Nov 03, 2023: CTL Amedica to Unveil MONDRIAN ALIF System Nov. 4 at the University of Miami 274

6.77 Nov 02, 2023: Life Spine Receives 510(K) Clearance For Pro-Link Ti Barbs Cervical Spacer System 274

6.78 Nov 02, 2023: Spineology Receives 510(K) Clearance For OptiMesh Multiplanar Expandable Interbody Fusion System 275

6.79 Nov 02, 2023: Medacta International Receives 510(K) Clearance For MectaLIF Anterior Lag Extension 275

6.80 Nov 02, 2023: Life Spine Receives Additional 510(k) Clearance for Pro-Link Cervical Spacer System 275

6.81 Nov 02, 2023: Ulrich Medical Receives Additional 510(k) Clearance for Momentum Posterior Spinal Fixation System 275

6.82 Nov 02, 2023: Ulrich Medical Receives an Additional 510(k) Clearance for Momentum MIS Posterior Spinal Fixation System 276

6.83 Oct 31, 2023: GBS Commonwealth Receives Additional 510(K) Clearance For Peridot-TD Anterior Cervical Intervertebral Body Fusion System 276

6.84 Oct 31, 2023: Innovasis Receives 510(K) Clearance For HAtetracell-C Titanium Cervical IBF System 276

6.85 Oct 30, 2023: Zimmer Biomet Spine Receives 510(K) Clearance For Vital Spinal Fixation System 276

6.86 Oct 30, 2023: Alphatec Spine Receives 510(K) Clearance For Calibrate CCX Interbody System 276

6.87 Oct 30, 2023: Spineway Receives 510(K) Clearance For VEOS Spinal Fixation System 277

6.88 Oct 30, 2023: Shanghai Sanyou Medical Has Receives Additional FDA 510(K) Clearance for Zeus Spinal System 277

6.89 Oct 30, 2023: Nexus Spine Receives Additional 510(K) Clearance For Stable-L Standalone Lumbar Interbody System 277

6.90 Oct 30, 2023: CarboFix Orthopedics Receives Additional FDA 510(K) Clearance for CarboClear Pedicle Screw System 277

6.91 Oct 30, 2023: GBS Commonwealth Receives Additional 510(K) Clearance For Peridot-TD Spacer System 277

6.92 Oct 26, 2023: Cutting Edge Spine Announces Notice of Issuance from the U.S. Patent And trademark Office Regarding Patent no.us 11,771,482 B2: Implants Fortissue Fixation and Fusion 278

6.93 Oct 19, 2023: 4WEB Medical Receives Additional 510(k) Clearance for Cervical Spinal Truss System (CSTS) Interbody Fusion Device 278

6.94 Oct 19, 2023: Wenzel Spine Obtains Additional 510(k) Clearance for VariLift-C 278

6.95 Oct 19, 2023: ulrich medical USA introduces Momentum MIS system 278

6.96 Oct 19, 2023: Intelivation Technologies Announces Expansion Into New Markets After Success of Golden Isles Pedicle Screw System 279

6.97 Oct 19, 2023: VEOS FDA 510(k) clearance 279

6.98 Oct 19, 2023: Expanding Innovations, Announces Commercial Launch of X-Pac Expandable Lateral Cage System 280

6.99 Oct 18, 2023: Mirus Announces FDA 510(K) Clearance for Molybdenum-Rhenium (More) Low Profile Anterior Cervical and Lateral Lumbar Plating Systems 281

6.100 Oct 17, 2023: VySpine Announces FDA Clearances for VySpan, VyLam and VySpine Innovations 281

6.101 Oct 16, 2023: Vy Spine Receives Additional 510(K) Clearance For VySpan PCT System 281

6.102 Oct 16, 2023: Alphatec Spine Receives Additional 510(K) Clearance For Invictus Spinal Fixation System 282

6.103 Oct 16, 2023: SMAIO Obtains Additional 510(K) Clearance For Kheiron Spinal Fixation System 282

6.104 Oct 16, 2023: LESspine Receives Additional 510(K) Clearance For Inspan ScrewLES Fusion System 282

6.105 Oct 16, 2023: LESspine Receives 510(K) Clearance For Invue MAX + Invue Inset Anterior Cervical Plate System 283

6.106 Oct 16, 2023: LESspine Receives 510(k) Clearance for Sacrix Sacroiliac Joint Fusion Device System 283

6.107 Oct 16, 2023: SAIL Fusion Announces First Implantations of its BowTie Sacroiliac Fusion System 283

6.108 Oct 12, 2023: SurGenTec Receives 510(K) Clearance for TiLink-P SI Joint Fusion System 283

6.109 Oct 12, 2023: Alphatec Spine Receives 510(K) Clearance For IdentiTi ALIF Interbody System 284

6.110 Oct 11, 2023: SpineGuard Announces its Q3 2023 Revenue 284

6.111 Oct 10, 2023: Medos International Receives 510(k) Clearance for TriALTIS Spine System 285

6.112 Oct 10, 2023: Xenix Medical neoWave Interbody Systems Receive FDA Clearance for NANOACTIV Nanotechnology Surface 285

6.113 Oct 09, 2023: Kleiner Device Labs Awarded Patent for KG2 Surge flow-thru interbody system 286

6.114 Oct 09, 2023: DePuy Synthes Receives FDA Clearance for the TriALTIS Spine System and Navigation Enabled Instruments 286

6.115 Oct 09, 2023: Stryker to Host Investor Day 287

6.116 Oct 06, 2023: Nexus Spine Receives Additional 510(K) Clearance for Stable-L Standalone Lumbar Interbody System 287

6.117 Oct 06, 2023: Nexus Spine Receives Additional 510(K) Clearance For Stable – C Interbody System 287

6.118 Oct 04, 2023: SurGenTec receives US FDA clearance for TiLink-P fusion system 288

6.119 Oct 04, 2023: Difusion Technologies Releases New Case Series Data on Device Poised to Revolutionize Spinal Surgeries 288

6.120 Oct 04, 2023: Medtronic Names Paolo Di Vincenzo President of the Neuromodulation Business 289

6.121 Oct 02, 2023: Kalitec Medical Obtains 510(k) Clearance for NIDO Pedicle Screw System 289

6.122 Oct 02, 2023: Stryker to Announce Financial Results for Its Third Quarter of Fiscal Year 2023 289

6.123 Sep 29, 2023: Choice Spine Obtains Additional 510(k) Clearance for Blackhawk Ti Cervical Spacer System 289

6.124 Sep 28, 2023: Spinal Cage FDA Submission Timeline Update 290

6.125 Sep 28, 2023: Spinal Simplicity Appoints Vice President of Brand Development 290

6.126 Sep 27, 2023: MiRus Receives 510(k) Clearance for MiRus 3DR Lateral Lumbar Interbody Fusion System 290

6.127 Sep 27, 2023: Kyocera Medical Technologies Receives 510(k) Clearance for Skyway Anterior Cervical Plate System 291

6.128 Sep 27, 2023: 4WEB Medical Receives 510k Clearance to Market New Integrated Cervical Plate 291

6.129 Sep 25, 2023: OrthoPediatrics was a Gold Level Sponsor of the Scoliosis Research Society 58th Annual Meeting 291

6.130 Sep 19, 2023: ChoiceSpine Announces Standalone Indication for Blackhawk Ti 3D Printed Cervical Spacer System 292

6.131 Sep 18, 2023: DeGen Medical Launches 3D-printed ALIF implant at Texas Back Institute with Drs. Peter Derman and Alexander Satin 292

6.132 Sep 14, 2023: Zavation Receives 510(k) Clearance for Zavation Connector System 293

6.133 Sep 14, 2023: Nexus Spine Receives Additional 510(k) Clearance for Stable – C Interbody System 293

6.134 Sep 14, 2023: Medyssey Receives Additional 510(k) Clearance for Zenius Spinal System 293

6.135 Sep 14, 2023: Tenon Medical Receives Additional 510(k) Clearance for Catamaran Sacroiliac Joint Fixation System 293

6.136 Sep 14, 2023: L & K Biomed Receives Additional 510(k) Clearance for AccelFix Lumbar Expandable Cage System 294

6.137 Sep 14, 2023: Smith & Nephew Brings BT Chief Financial Officer Simon Lowth to Board 294

6.138 Sep 14, 2023: New Non Executive Directors Join the Board at Med Tech Business 294

6.139 Sep 14, 2023: Smith & Nephew Announces Board Changes 294

6.140 Sep 12, 2023: Orthofix Announces Leadership Changes 295

6.141 Sep 12, 2023: SpineGuard Reports Six-Month 2023 Financial Results 296

6.142 Sep 07, 2023: University of Connecticut : A 3D-Printed Solution for the Spine 298

6.143 Sep 05, 2023: L & K Biomed Receives Additional 510(k) Clearance for LnK Spinal Fixation System 299

6.144 Sep 05, 2023: L & K Biomed Obtains Additional 510(k) Clearance for OpenLoc-L Spinal Fixation System 299

6.145 Sep 05, 2023: L & K Biomed Receives Additional 510(k) Clearance for AccelFix Spinal Fixation System 300

6.146 Sep 05, 2023: ZSFab Receives an Additional 510(k) Clearance for ZSFab Cervical Interbody System 300

6.147 Sep 05, 2023: SI-Bone, Announces iFuse Bedrock Granite Implant System Compatibility With Certain Medtronic CD Horizon Solera

5.5/6.0 System Rods 300

6.148 Sep 05, 2023: Zimmer Biomet Announces Key Updates to Company’s Executive Leadership Team 301

6.149 Aug 30, 2023: Mesoblast Reports Financial Results and Operational Update for Fiscal Year Ended June 30, 2023 301

6.150 Aug 30, 2023: NuVasive to Participate as Double Diamond Sponsor at Scoliosis Research Society Annual Meeting 303

6.151 Aug 28, 2023: Orthofix Announces First Cases and Full Commercial Launch of the 7D FLASH Navigation System Percutaneous Module

2.0 for Minimally Invasive Surgery 304

6.152 Aug 26, 2023: Medtronic Q2 2024 Earnings Estimates Increased by William Blair 304

6.153 Aug 25, 2023: Southern Medical Receives 510(k) Clearance for SPICCA Cervical Fusion Cage 304

6.154 Aug 25, 2023: Southern Medical Receives 510(k) Clearance for SPICCA Stand-Alone Cervical Fusion Cage 304

6.155 Aug 25, 2023: Medtronic Sofamor Danek Receives 510(k) Clearance for CD Horizon ModuLeX FNS Fenestrated Screw Set 305

6.156 Aug 25, 2023: Medtronic Sofamor Danek Receives 510(k) Clearance for CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) 305

6.157 Aug 23, 2023: Wenzel Spine secures FDA clearance to update indications for spinal fusion technology 305

6.158 Aug 23, 2023: Aurora Spine Corp. Announces Second Quarter Fiscal 2023 Financial Results 306

6.159 Aug 22, 2023: Providence Medical Technology Receives 510(k) Clearance for Expandable Cage 307

6.160 Aug 22, 2023: Zimmer Biomet Announces Leadership Transition 307

6.161 Aug 21, 2023: Accelus Receives Additional 510(k) Clearance for LineSider Spinal System 308

6.162 Aug 18, 2023: Spinal Elements Receives 510(k) Clearance for Sapphire X3 Anterior Cervical Plate System 308

6.163 Aug 18, 2023: Globus Medical Receives 510(k) Clearance for Lumbar Expandable lnterbody Spacer 308

6.164 Aug 18, 2023: SAGICO USA Receives 510(k) Clearance for Titus Titanium Cervical Device 308

6.165 Aug 16, 2023: 4WEB Medical commercially introduces new cervical spine plate 309

6.166 Aug 16, 2023: SeaSpine Orthopedics Receives an Additional 510(k) Clearance for NorthStar OCT Spinal System 309

6.167 Aug 15, 2023: Shanghai Sanyou Medical Receives Additional 510(k) Clearance for Adena-Zina System 309

6.168 Aug 10, 2023: Spine Wave Receives 510(k) Clearance for Exceed Biplanar Expandable Interbody System 310

6.169 Aug 10, 2023: CarboFix Orthpedics Receives 510(k) Clearance for CarboClear Cervical Cage System 310

6.170 Aug 08, 2023: Medtronic to Announce Financial Results for its First Quarter of Fiscal Year 2024 310

6.171 Aug 07, 2023: 3D Systems & Theradaptive Establish Commercial Partnership to Advance Orthopedic & Soft Tissue Repair Using Breakthrough Regenerative Therapeutics 310

6.172 Aug 04, 2023: Spinal Cage FDA Submission Update – Supplementary Announcement 311

6.173 Aug 04, 2023: Spinal Cage FDA Submission – Timeline Update 311

6.174 Jul 31, 2023: L & K Biomed Receives Additional 510(k) Clearance for AccelFix Lumbar Plate System 312

6.175 Jul 31, 2023: L & K Biomed Receives Additional 510(k) Clearance for CastleLoc-P Anterior Cervical Plate System 312

6.176 Jul 31, 2023: L & K Biomed Receives Additional 510(k) Clearance for CastleLoc-S Posterior Cervical Fixation System 312

6.177 Jul 31, 2023: Nexxt Spine Receives Additional 510(k) Clearance for INERTIA CONNEXX Modular Pedicle Screw System 312

6.178 Jul 28, 2023: Gs Medical Receives 510(K) Clearance for QUASAR Standalone ACIF System 313

6.179 Jul 28, 2023: Medacta Group Announces 2023 Half-Year Unaudited Top-Line Figures 313

6.180 Jul 26, 2023: Inspired Spine’s Dr. Abbasi Presents OLLIF to Seattle Science Foundation 314

6.181 Jul 25, 2023: NuVasive Receives Additional 510(K) Clearance for CoRoent Small Interbody System – Four Contiguous Levels 315

6.182 Jul 25, 2023: NuVasive Receives Additional 510(K) Clearance for NuVasive CoRoent Small Interlock II System 315

6.183 Jul 25, 2023: NuVasive Receives Additional 510(K) Clearance for NuVasive CoRoent Small Interlock System 315

6.184 Jul 25, 2023: NuVasive Receives Additional 510(K) Clearance for COHERE Cervical Interbody Fusion Device 315

6.185 Jul 25, 2023: NuVasive Receives Additional 510(K) Clearance for CoRoent Small Interbody System 316

6.186 Jul 25, 2023: L & K Biomed Receives Additional 510(K) Clearance for PathLoc-SI Joint Fusion System 316

6.187 Jul 25, 2023: Huvexel Receives Additional 510(K) Clearance for Balteum Lumbar Plate System 316

6.188 Jul 25, 2023: Huvexel Receives Additional 510(K) Clearance for Rex Anterior Cervical Plate System 316

6.189 Jul 25, 2023: Huvexel Receives Additional 510(K) Clearance for Fortis and Hana Anterior Cervical Plate System 317

6.190 Jul 25, 2023: Huvexel Receives Additional 510(K) Clearance for BALTEUM ONE Lumbar Plate System 317

6.191 Jul 24, 2023: Camber Spine Technologies Receives FDA 510(K) Clearance for SPIRA Posterior Lumbar Spacer 317

6.192 Jul 24, 2023: NuVasive Receives FDA 510(K) Clearance for NuVasive CoRoent Small Ti-C System 317

6.193 Jul 24, 2023: NanoHive Medical Receives FDA 510(K) Clearance for Lumbar Interbody System 317

6.194 Jul 24, 2023: K&J Consulting Receives FDA 510(K) Clearance for Osprey Anterior Cervical Plate System 318

6.195 Jul 24, 2023: Alphatec Spine Receives FDA 510(K) Clearance for Calibrate PSX Interbody System 318

6.196 Jul 24, 2023: Alphatec Spine Receives FDA 510(K) Clearance for Calibrate NanoTec PSX Interbody System 318

6.197 Jul 21, 2023: Spinal Simplicity Receives FDA 510(K) Clearance for Edge Upper Cervical System 318

6.198 Jul 19, 2023: Cerapedics Announces Expansion of Headquarters to Support Growth of Its Bone Graft Products 318

6.199 Jul 18, 2023: CarboFix Orthopedics Receives Additional 510(k) Clearance for CarboClear X Pedicle Screw System 319

6.200 Jul 18, 2023: Premia Spine Receives Additional 510(k) Clearance for ProMIS Fixation System 319

6.201 Jul 18, 2023: Curiteva Announces World’s First 3D Printed PEEK Device With Regulatory Clearance Reaches Full Commercial Launch in the United States 319

6.202 Jul 14, 2023: CarboFix Orthopedics Receives 510(k) Clearance for CarboClear X Fenestrated Pedicle Screw System with High V+ Bone Cement 320

6.203 Jul 14, 2023: Nvision Biomedical Technologies Receives 510(k) Clearance for Integral Titanium Cervical Interbody 320

6.204 Jul 14, 2023: Bioretec appoints Esa Hallinen as a director of operations and a member of the Management Team 320

6.205 Jul 13, 2023: Spinal Elements Receives 510(k) Clearance for Ventana L Spinal System 321

6.206 Jul 12, 2023: L & K Biomed Receives an Additional 510(k) Clearance for LnK Spinal Fixation System 321

6.207 Jul 12, 2023: L & K Biomed Receives an Additional 510(k) Clearance for AccelFix Spinal Fixation System 321

6.208 Jul 12, 2023: L & K Biomed Receives an Additional 510(k) Clearance for OpenLoc-L Spinal Fixation System 321

6.209 Jul 12, 2023: SAGICO Receives 510(k) Clearance for SAGICO Spinal System 322

6.210 Jul 11, 2023: CGBio obtains the third permit for cervical cage Novomax-Fusion in Japan following the permits received from Europe and Australia 322

6.211 Jul 07, 2023: Pioneer Surgical Technology Receives Additional 510(k) Clearance for CODA Anterior Cervical Plate System 323

6.212 Jul 07, 2023: Spineart Geneva Receives Additional 510(k) Clearance for PERLA TL Posterior Osteosynthesis System 323

6.213 Jul 05, 2023: DeGen Medical Receives 510(k) Clearance for Solar Lumbar Interbody Fusion System 323

6.214 Jul 05, 2023: NuVasive Receives Additional 510(k) Clearance for Modulus ALIF System 323

6.215 Jul 05, 2023: JMT Receives Additional 510(k) Clearance for EDEN Spinal Fixation System 324

6.216 Jul 05, 2023: Medtronic Receives Additional 510(k) Clearance for Zevo Anterior Cervical Plate System 324

6.217 Jul 04, 2023: Southern Medical Receives 510(k) Clearance for Axis Anterior Cervical Plate System 324

6.218 Jul 04, 2023: Zavation Receives 510(k) Clearance for Zavation ALIF System 324

6.219 Jun 30, 2023: Biosenic Provides Financial Update 324

6.220 Jun 28, 2023: Aurora Spine Announces Initial Patient Enrolled for DEXA-C Multicenter Study 325

6.221 Jun 26, 2023: Corelink Receives 510(k) Clearance for F3D Interbody System 325

6.222 Jun 26, 2023: CTL Amedica Receives 510(k) Clearance for RODIN Expandable Lumbar Cage System 326

6.223 Jun 26, 2023: Genesys Spine Launches SIros O Transfixing SI Joint Fusion System 326

6.224 Jun 25, 2023: Xenco Medical Receives 510(k) Clearance for InterAlign Cervical Interbody System 326

6.225 Jun 21, 2023: IMPLANET Announces the European Launch of the MIS Range, a Minimally Invasive Pedicle Screw System 326

6.226 Jun 20, 2023: Orthofix introduces WaveForm A interbody for ALIF procedures 327

7 Appendix 382

7.1 Methodology 382

7.2 About GlobalData 385

7.3 Contact Us 385

7.4 Disclaimer 385

Table

Spinal Fusion – Pipeline Products by Stage of Development 28

Spinal Fusion – Pipeline Products by Segment 29

Spinal Fusion – Pipeline Products by Territory 30

Spinal Fusion – Pipeline Products by Regulatory Path 31

Spinal Fusion – Pipeline Products by Estimated Approval Date 32

Spinal Fusion – Ongoing Clinical Trials 33

Spinal Fusion Companies – Pipeline Products by Stage of Development 34

Spinal Fusion – Pipeline Products by Stage of Development 39

Acuitive Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Citrefuse – Product Status 44

Citrefuse – Product Description 44

Allegra Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 45

Sr-HT-Gahnite Spinal Cage Device – Product Status 45

Sr-HT-Gahnite Spinal Cage Device – Product Description 45

ALM Ortho Inc Pipeline Products & Ongoing Clinical Trials Overview 46

Lateral Intervertebral Fusion Cage – Product Status 46

Lateral Intervertebral Fusion Cage – Product Description 46

SI Joint Fusion Device – Product Status 47

SI Joint Fusion Device – Product Description 47

Alphatec Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 48

BioScorp – Product Status 48

BioScorp – Product Description 49

Helifuse – Product Status 49

Helifuse – Product Description 49

OsseoFix Next Generation Implant – Product Status 50

OsseoFix Next Generation Implant – Product Description 50

OsseoSleeve – Product Status 50

OsseoSleeve – Product Description 51

PCB – Product Status 51

PCB – Product Description 51

Samarys RF – Product Status 52

Samarys RF – Product Description 52

AMB Surgical II LLC Pipeline Products & Ongoing Clinical Trials Overview 53

FLYTE SPINE – Product Status 53

FLYTE SPINE – Product Description 53

APTO Orthopaedics Pipeline Products & Ongoing Clinical Trials Overview 54

Pediatric Spinal Fixation System – Product Status 54

Pediatric Spinal Fixation System – Product Description 54

Aurora Spine Corp Pipeline Products & Ongoing Clinical Trials Overview 55

Restore Kyphoplasty System – Product Status 55

Restore Kyphoplasty System – Product Description 55

SiLO-FX Fusion System – Product Status 56

SiLO-FX Fusion System – Product Description 56

VOX 2.0 – Product Status 56

VOX 2.0 – Product Description 57

Biedermann Motech GmbH & Co KG Pipeline Products & Ongoing Clinical Trials Overview 58

Mesh – Product Status 58

Mesh – Product Description 58

Bio2 Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 59

Vitrium – Cervical Interbody Fusion Device – Product Status 59

Vitrium – Cervical Interbody Fusion Device – Product Description 59

Vitrium – Lumbar Interbody Fusion Device – Product Status 60

Vitrium – Lumbar Interbody Fusion Device – Product Description 60

Bioretec Ltd Pipeline Products & Ongoing Clinical Trials Overview 61

RemeOs Spinal Cage – Product Status 61

RemeOs Spinal Cage – Product Description 61

Spinal Plate – Spinal Osteosynthesis – Product Status 62

Spinal Plate – Spinal Osteosynthesis – Product Description 62

Butterfly Spine, LLC Pipeline Products & Ongoing Clinical Trials Overview 63

Interspinous Dynamic Fusion Device – Product Status 63

Interspinous Dynamic Fusion Device – Product Description 63

Camber Spine Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 64

SPIRA – Expandable Transforaminal Lumbar Interbody – Product Status 64

SPIRA – Expandable Transforaminal Lumbar Interbody – Product Description 64

SPIRA – Sacroiliac – Product Status 65

SPIRA – Sacroiliac – Product Description 65

SPIRA Posterior Lumbar – Product Status 65

SPIRA Posterior Lumbar – Product Description 66

Carlsmed Inc Pipeline Products & Ongoing Clinical Trials Overview 67

Aprevo Cervical Spine Interbody Fusion Device – Product Status 67

Aprevo Cervical Spine Interbody Fusion Device – Product Description 67

Choice Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 68

Expandable PEEK Interbody Cage – Product Status 68

Expandable PEEK Interbody Cage – Product Description 68

Next Generation Gibralt Spine System – Product Status 69

Next Generation Gibralt Spine System – Product Description 69

Next Generation Proliant Spine System – Product Status 69

Next Generation Proliant Spine System – Product Description 69

Clariance Inc Pipeline Products & Ongoing Clinical Trials Overview 70

Platform Access – Product Status 70

Platform Access – Product Description 70

Clariance SAS Pipeline Products & Ongoing Clinical Trials Overview 71

Erisma Deformity – Product Status 71

Erisma Deformity – Product Description 71

Clariance SAS – Ongoing Clinical Trials Overview 72

Erisma Deformity – Clariance Registry of ERISMA and Idys Devices 73

Corelink LLC Pipeline Products & Ongoing Clinical Trials Overview 74

3D Printed Cervical Titanium Interbody System – Product Status 74

3D Printed Cervical Titanium Interbody System – Product Description 74

3D Printed Lumbar Titanium Interbody System – Product Status 75

3D Printed Lumbar Titanium Interbody System – Product Description 75

Cervical Plate System – Product Status 75

Cervical Plate System – Product Description 75

Stand Alone Cervical Cage System – Product Status 76

Stand Alone Cervical Cage System – Product Description 76

Universal Pedicle Screw System – Product Status 76

Universal Pedicle Screw System – Product Description 76

Cortical Concepts (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 77

Cortical Anchor – Product Status 77

Cortical Anchor – Product Description 77

CTL Amedica Corp Pipeline Products & Ongoing Clinical Trials Overview 78

Sneak Peak – Product Status 78

Sneak Peak – Product Description 78

Curiteva Inc Pipeline Products & Ongoing Clinical Trials Overview 79

Inspire PLIF Interbody Implant – Product Status 79

Inspire PLIF Interbody Implant – Product Description 79

Inspire Standalone ALIF Interbody Implant – Product Status 80

Inspire Standalone ALIF Interbody Implant – Product Description 80

Inspire Static ALIF Interbody Implant – Product Status 80

Inspire Static ALIF Interbody Implant – Product Description 81

Inspire TLIF Interbody Implant – Product Status 81

Inspire TLIF Interbody Implant – Product Description 81

Cutting Edge Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 82

EVOL HA-ALIF – Product Status 82

EVOL HA-ALIF – Product Description 82

Ventral Cervical Plate – Product Status 83

Ventral Cervical Plate – Product Description 83

DePuy Synthes Inc Pipeline Products & Ongoing Clinical Trials Overview 84

Expandable Cage – Spine – Product Status 84

Expandable Cage – Spine – Product Description 84

Expedium FAS 2 – Product Status 85

Expedium FAS 2 – Product Description 85

DSM Biomedical BV Pipeline Products & Ongoing Clinical Trials Overview 86

Graft Containment Device – Product Status 86

Graft Containment Device – Product Description 86

Porous Resorbable Interbody Spacer – Product Status 87

Porous Resorbable Interbody Spacer – Product Description 87

Spine Inter-Body Fusion Cage – Product Status 87

Spine Inter-Body Fusion Cage – Product Description 88

Structural Spine Implant – Product Status 88

Structural Spine Implant – Product Description 88

DSM Dyneema BV Pipeline Products & Ongoing Clinical Trials Overview 89

Dyneema Purity – Scoliosis – Product Status 89

Dyneema Purity – Scoliosis – Product Description 89

Eden Spine LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 90

PERFX-1 – Product Status 90

PERFX-1 – Product Description 90

EDGe Surgical Inc Pipeline Products & Ongoing Clinical Trials Overview 91

Next Gen Spine Awl-In-One Tap System – Product Status 91

Next Gen Spine Awl-In-One Tap System – Product Description 91

EIT Emerging Implant Technologies GmbH Pipeline Products & Ongoing Clinical Trials Overview 92

Fully Printed Lateral Expanding Cage – Product Status 92

Fully Printed Lateral Expanding Cage – Product Description 92

Eminent Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 93

Anaconda – Product Status 93

Anaconda – Product Description 93

King Snake – Product Status 94

King Snake – Product Description 94

Queen Snake – Product Status 94

Queen Snake – Product Description 95

ErgoSpine Pipeline Products & Ongoing Clinical Trials Overview 96

ErgoFuse – Product Status 96

ErgoFuse – Product Description 96

Evoke Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 97

eHeal – Product Status 97

eHeal – Product Description 97

FacetMed Ltd Pipeline Products & Ongoing Clinical Trials Overview 98

DualAxis – Product Status 98

DualAxis – Product Description 98

PediWing Spinal Fixation System – Product Status 99

PediWing Spinal Fixation System – Product Description 99

Fuse Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 100

Cervical Spinal Interbody Device – Product Status 100

Cervical Spinal Interbody Device – Product Description 100

Lumbar Spinal Interbody Device – Product Status 101

Lumbar Spinal Interbody Device – Product Description 101

GS Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 102

AnyPlus Anterior Cervical Plate – Product Status 102

AnyPlus Anterior Cervical Plate – Product Description 102

AnyPlus Posterior Cervical OCT Plate And Screw System – Product Status 103

AnyPlus Posterior Cervical OCT Plate And Screw System – Product Description 103

Chrome Cobalt Rod System – Product Status 103

Chrome Cobalt Rod System – Product Description 104

H. Lee Moffitt Cancer Center & Research Institute Inc Pipeline Products & Ongoing Clinical Trials Overview 105

Laterally Expanding Cage – Product Status 105

Laterally Expanding Cage – Product Description 105

Transdiscal Screw System – Product Status 106

Transdiscal Screw System – Product Description 106

HAPPE Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 107

Lumbar PEEK Interbody Device – ALIF – Product Status 107

Lumbar PEEK Interbody Device – ALIF – Product Description 107

Lumbar PEEK Interbody Device – TLIF – Product Status 108

Lumbar PEEK Interbody Device – TLIF – Product Description 108

HD LifeSciences LLC Pipeline Products & Ongoing Clinical Trials Overview 109

Hive Cervical – Product Status 109

Hive Cervical – Product Description 109

Hospital for Special Surgery Pipeline Products & Ongoing Clinical Trials Overview 110

Percutaneous Graft Delivery System – Product Status 110

Percutaneous Graft Delivery System – Product Description 110

Implanet SA Pipeline Products & Ongoing Clinical Trials Overview 111

Hybrid Fixation System – Product Status 111

Hybrid Fixation System – Product Description 112

ISS-JAZZ Screw System – Product Status 112

ISS-JAZZ Screw System – Product Description 112

Jazz Cap System – Product Status 113

Jazz Cap System – Product Description 113

JAZZ Evo – Product Status 113

JAZZ Evo – Product Description 113

Jazz Lock – Product Status 114

Jazz Lock – Product Description 114

JAZZ Passer Band – Product Status 114

JAZZ Passer Band – Product Description 115

JAZZ Standalone Implant – Product Status 115

JAZZ Standalone Implant – Product Description 115

Spinal Deformity Device – Product Status 116

Spinal Deformity Device – Product Description 116

Inion Oy Pipeline Products & Ongoing Clinical Trials Overview 117

Lumbar Cage – Product Status 117

Lumbar Cage – Product Description 117

Innospina LLC Pipeline Products & Ongoing Clinical Trials Overview 118

Spinal Fusion Implant – Product Status 118

Spinal Fusion Implant – Product Description 118

Intelligent Implant Systems LLC Pipeline Products & Ongoing Clinical Trials Overview 119

LSIF – Product Status 119

LSIF – Product Description 119

Mind Lumbar-Thoracic Spinal System – Product Status 120

Mind Lumbar-Thoracic Spinal System – Product Description 120

Intelligent Implants Pipeline Products & Ongoing Clinical Trials Overview 121

SmartFuse System – Product Status 121

SmartFuse System – Product Description 121

Jemo Spine, LLC. Pipeline Products & Ongoing Clinical Trials Overview 122

Alta – Anterior Cervical Plate – Product Status 122

Alta – Anterior Cervical Plate – Product Description 122

Moab Interbody Spacer – Product Status 123

Moab Interbody Spacer – Product Description 123

joimax GmbH Pipeline Products & Ongoing Clinical Trials Overview 124

Disc Preparation Tool – LIF – Product Status 124

Disc Preparation Tool – LIF – Product Description 124

LESspine LLC Pipeline Products & Ongoing Clinical Trials Overview 125

Expanding P-Lift – Product Status 125

Expanding P-Lift – Product Description 125

PedFuse REly – Product Status 126

PedFuse REly – Product Description 126

SIJ-Fuse Rod – Product Status 126

SIJ-Fuse Rod – Product Description 127

VBR (Vertebral Body Replacement) Device – Product Status 127

VBR (Vertebral Body Replacement) Device – Product Description 127

X-Visibl – Product Status 128

X-Visibl – Product Description 128

Lifespans Ltd Pipeline Products & Ongoing Clinical Trials Overview 129

Lifespans Soft Spine Implant – Product Status 129

Lifespans Soft Spine Implant – Product Description 129

Maxigen Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 130

MaxiCage – Product Status 130

MaxiCage – Product Description 130

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 131

Pedicle Screw Washer – Product Status 131

Pedicle Screw Washer – Product Description 131

Medicrea Group Pipeline Products & Ongoing Clinical Trials Overview 132

Corpectomy Implant – Product Status 132

Corpectomy Implant – Product Description 132

Medos International Sarl Pipeline Products & Ongoing Clinical Trials Overview 133

TriALTIS Spine System – Product Status 133

TriALTIS Spine System – Product Description 133

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 134

Anterior L1/S1 Spine Plates – Product Status 134

Anterior L1/S1 Spine Plates – Product Description 134

Osteoporosis And Cannulated Pedicle Screw System – Product Status 135

Osteoporosis And Cannulated Pedicle Screw System – Product Description 135

Solera Fenestrated Screw – Product Status 135

Solera Fenestrated Screw – Product Description 135

U Spine II – Product Status 136

U Spine II – Product Description 136

Medyssey Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 137

ATHENA – Product Status 137

ATHENA – Product Description 137

Mekanika Inc Pipeline Products & Ongoing Clinical Trials Overview 138

Modulus System – Product Status 138

Modulus System – Product Description 138

Mercy Health Research Pipeline Products & Ongoing Clinical Trials Overview 139

Spinous Process Device – Product Status 139

Spinous Process Device – Product Description 139

Mesoblast Ltd Pipeline Products & Ongoing Clinical Trials Overview 140

NeoFuse – Product Status 140

NeoFuse – Product Description 140

MI4 Spine, LLC Pipeline Products & Ongoing Clinical Trials Overview 141

Cervical Plate – Product Status 141

Cervical Plate – Product Description 141

MIS Interspinous Process Spacer – Product Status 142

MIS Interspinous Process Spacer – Product Description 142

MIS Pedicle Screw – Product Status 142

MIS Pedicle Screw – Product Description 143

PLIF/TLIF System – Product Status 143

PLIF/TLIF System – Product Description 143

Michigan State University Pipeline Products & Ongoing Clinical Trials Overview 144

X-Plant Spinal Fixator – Product Status 144

X-Plant Spinal Fixator – Product Description 144

MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 145

Spine Plate – Product Status 145

Spine Plate – Product Description 145

Spine Screw – Product Status 146

Spine Screw – Product Description 146

N8 Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 147

Coated Pedicle Screw – Product Status 147

Coated Pedicle Screw – Product Description 147

Nanovis Inc Pipeline Products & Ongoing Clinical Trials Overview 148

FortiSpan CrossLink – Product Status 148

FortiSpan CrossLink – Product Description 148

Nasseo, Inc. Pipeline Products & Ongoing Clinical Trials Overview 149

3D Printed Spinal Implant – Product Status 149

3D Printed Spinal Implant – Product Description 149

NEOS Surgery SL Pipeline Products & Ongoing Clinical Trials Overview 150

NEOS Pedicle Screw System – Product Status 150

NEOS Pedicle Screw System – Product Description 150

Neumedix Surgical Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 151

NeuMedix Expanding Cervical Canal Device – Product Status 151

NeuMedix Expanding Cervical Canal Device – Product Description 151

Nexilis AG Pipeline Products & Ongoing Clinical Trials Overview 152

Immediate Stabilization System – Product Status 152

Immediate Stabilization System – Product Description 152

Nexxt Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 153

Bone Healing Spinal Implant – Product Status 153

Bone Healing Spinal Implant – Product Description 153

Integrated Plate System – Product Status 154

Integrated Plate System – Product Description 154

Novadip Biosciences SA Pipeline Products & Ongoing Clinical Trials Overview 155

NVD-001 – Product Status 155

NVD-001 – Product Description 155

Novum Medical Products, Inc. Pipeline Products & Ongoing Clinical Trials Overview 156

Anterior Lumbar Interbody Fusion Device – Product Status 156

Anterior Lumbar Interbody Fusion Device – Product Description 156

Lateral Lumbar Interbody Fusion Device – Product Status 157

Lateral Lumbar Interbody Fusion Device – Product Description 157

Nutech Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 158

NuFix II Facet Fusion Dowel – Product Status 158

NuFix II Facet Fusion Dowel – Product Description 158

NuVasive Inc Pipeline Products & Ongoing Clinical Trials Overview 159

Reline Complex – Product Status 159

Reline Complex – Product Description 159

Reline Edge – Product Status 160

Reline Edge – Product Description 160

Reline One – Product Status 160

Reline One – Product Description 160

Orchid Orthopedic Solutions LLC Pipeline Products & Ongoing Clinical Trials Overview 161

Thru-Fuze Device – Product Status 161

Thru-Fuze Device – Product Description 161

Orthobond Pipeline Products & Ongoing Clinical Trials Overview 162

Antimicrobial Pedicle Screw System – Product Status 162

Antimicrobial Pedicle Screw System – Product Description 162

Osseus Fusion Systems LLC Pipeline Products & Ongoing Clinical Trials Overview 163

Next Generation Aries – Cervical – Product Status 163

Next Generation Aries – Cervical – Product Description 163

Next Generation Aries – Expandable Lumbar Fusion Cage – Product Status 164

Next Generation Aries – Expandable Lumbar Fusion Cage – Product Description 164

OsteoGeneX Inc Pipeline Products & Ongoing Clinical Trials Overview 165

Spinal Fusion Device – Product Status 165

Spinal Fusion Device – Product Description 165

OsteoVantage Inc Pipeline Products & Ongoing Clinical Trials Overview 166

INDOS System – Product Status 166

INDOS System – Product Description 166

Ozop Surgical Corp (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 167

Adjustable ALIF Interbody Spinal Implant – Product Status 167

Adjustable ALIF Interbody Spinal Implant – Product Description 167

Pharmaco-Kinesis Corp Pipeline Products & Ongoing Clinical Trials Overview 168

Intelligent Interbody Fusion Device – Product Status 168

Intelligent Interbody Fusion Device – Product Description 168

Providence Medical Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 169

Posterior Cervical Stabilization System – Product Status 169

Posterior Cervical Stabilization System – Product Description 169

Providence Medical Technology Inc – Ongoing Clinical Trials Overview 170

Posterior Cervical Stabilization System – Safety and Effectiveness of Posterior Cervical Stabilization System (PCSS) as an Adjunct to Posterior Cervical Fusion, When Used in Combination with ACDF in Treatment of Multi-level Cervical Degenerative Disease 171

RegeneEx Ltd. Pipeline Products & Ongoing Clinical Trials Overview 172

RegeneEx Minimally Invasive Device – Product Status 172

RegeneEx Minimally Invasive Device – Product Description 172

Resoimplant GmbH (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 173

Resospine – Product Status 173

Resospine – Product Description 173

RevBio Inc Pipeline Products & Ongoing Clinical Trials Overview 174

Tetranite – Spine Fusion – Product Status 174

Tetranite – Spine Fusion – Product Description 174

ReVivo Medical, LLC Pipeline Products & Ongoing Clinical Trials Overview 175

Cervical Spinal Fusion Plate – Product Status 175

Cervical Spinal Fusion Plate – Product Description 175

Sail Fusion LLC Pipeline Products & Ongoing Clinical Trials Overview 176

BowTie Sacroiliac Fusion System – Product Status 176

BowTie Sacroiliac Fusion System – Product Description 176

Sail Fusion LLC – Ongoing Clinical Trials Overview 177

BowTie Sacroiliac Fusion System – A Pilot Clinical Study to Assess the Effects of the Novel BowTie Sacroiliac Fusion System 178

SANUWAVE Health Inc Pipeline Products & Ongoing Clinical Trials Overview 179

orthoPACE – Spinal Fusion – Product Status 179

orthoPACE – Spinal Fusion – Product Description 179

SeaSpine, Inc. Pipeline Products & Ongoing Clinical Trials Overview 180

PROW – Degenerative Disc Disease – Product Status 180

PROW – Degenerative Disc Disease – Product Description 180

Signus Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 181

Axioma-C – Product Status 181

Axioma-C – Product Description 181

SINTX Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 182

3DP SN-PEEK Cervical Implant – Product Status 182

3DP SN-PEEK Cervical Implant – Product Description 182

Biologically Enhanced Spinal Fusion Device – Product Status 183

Biologically Enhanced Spinal Fusion Device – Product Description 183

Composite Silicon Nitride Interbody Device – Product Status 183

Composite Silicon Nitride Interbody Device – Product Description 183

FleX SN Porous Spinal Implant – Product Status 184

FleX SN Porous Spinal Implant – Product Description 184

Spinal Balance Inc. Pipeline Products & Ongoing Clinical Trials Overview 185

Bioactive Facet Screw System – Product Status 185

Bioactive Facet Screw System – Product Description 185

Interbody Cage – Product Status 186

Interbody Cage – Product Description 186

Spinal Elements Inc Pipeline Products & Ongoing Clinical Trials Overview 187

Zyre Facet Implant System – Product Status 187

Zyre Facet Implant System – Product Description 187

Spinal Resources Inc Pipeline Products & Ongoing Clinical Trials Overview 188

Swedge Pedicle Screw Fixation System – 4.75 mm – Product Status 188

Swedge Pedicle Screw Fixation System – 4.75 mm – Product Description 189

Swedge Pedicle Screw Fixation System – 5.0 mm – Product Status 189

Swedge Pedicle Screw Fixation System – 5.0 mm – Product Description 190

Swedge Posterior Cervical Stabilization System – Product Status 190

Swedge Posterior Cervical Stabilization System – Product Description 190

Spinal Simplicity LLC Pipeline Products & Ongoing Clinical Trials Overview 191

Scarab – Product Status 191

Scarab – Product Description 191

SpinalVu Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 192

X – Wave Cervical Interbody Spacer – Product Status 192

X – Wave Cervical Interbody Spacer – Product Description 192

X – Wave Lumbar Interbody Spacer – Product Status 193

X – Wave Lumbar Interbody Spacer – Product Description 193

Spine Wave Inc Pipeline Products & Ongoing Clinical Trials Overview 194

CapSure PS2 Spine System – Product Status 194

CapSure PS2 Spine System – Product Description 194

SpineGuard SA Pipeline Products & Ongoing Clinical Trials Overview 195

PediGuard Spine SmartScrew – Product Status 195

PediGuard Spine SmartScrew – Product Description 195

SpineSmith Holdings LLC Pipeline Products & Ongoing Clinical Trials Overview 196

Cervical Interbody Device – Product Status 196

Cervical Interbody Device – Product Description 196

Closed VisuALIF – Product Status 197

Closed VisuALIF – Product Description 197

Facet Fixation Device – Product Status 197

Facet Fixation Device – Product Description 198

Posterior Lumbar Interbody Fusion Device – Product Status 198

Posterior Lumbar Interbody Fusion Device – Product Description 198

SpineVision SA Pipeline Products & Ongoing Clinical Trials Overview 199

Flex+2 – Product Status 199

Flex+2 – Product Description 199

Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 200

Spinal Fixation System – Product Status 200

Spinal Fixation System – Product Description 200

Stryker Corp Pipeline Products & Ongoing Clinical Trials Overview 201

AlloCraft C-Ring – Product Status 201

AlloCraft C-Ring – Product Description 201

Bioactive Inter-body Device – Product Status 202

Bioactive Inter-body Device – Product Description 202

Spiral Radius 90D Spinal System – Product Status 202

Spiral Radius 90D Spinal System – Product Description 203

Taragenyx Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 204

TRGYX-001 – Product Status 204

TRGYX-001 – Product Description 204

Theradaptive Inc Pipeline Products & Ongoing Clinical Trials Overview 205

OsteoAdapt SP Spinal Fusion Implant – Product Status 205

OsteoAdapt SP Spinal Fusion Implant – Product Description 205

Theradaptive Inc – Ongoing Clinical Trials Overview 206

OsteoAdapt SP Spinal Fusion Implant – OsteoAdapt SP Feasibility Study A Prospective, Blinded, Controlled, Dose-Randomized Clinical Investigation of OsteoAdapt SP in Transforaminal Lumbar Interbody Fusion in Treatment of Symptomatic Degenerative Disease of The Lumbosacral Spine 207

Tissue Regeneration Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 208

TRS Bioactive Implant – Spinal Fusion Surgery – Product Status 208

TRS Bioactive Implant – Spinal Fusion Surgery – Product Description 208

TranS1 Inc Pipeline Products & Ongoing Clinical Trials Overview 209

KeyLIF – Product Status 209

KeyLIF – Product Description 209

TruSpine Technologies Plc Pipeline Products & Ongoing Clinical Trials Overview 210

Cervi-LOK – Product Status 210

Cervi-LOK – Product Description 210

Faci-LOK – Product Status 211

Faci-LOK – Product Description 211

GRASP Laminoplasty Device – Product Status 211

GRASP Laminoplasty Device – Product Description 212

University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 213

Laminoplasty Distractor System – Product Status 213

Laminoplasty Distractor System – Product Description 213

University of Colorado Anschutz Medical Campus Pipeline Products & Ongoing Clinical Trials Overview 214

Anterior Cervical Plating System – Product Status 214

Anterior Cervical Plating System – Product Description 214

University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview 215

Self-Powered Smart Implant – Product Status 215

Self-Powered Smart Implant – Product Description 215

University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 216

Asymmetric Disc Distracting Cage – Product Status 216

Asymmetric Disc Distracting Cage – Product Description 216

Cervical Plating System – Product Status 217

Cervical Plating System – Product Description 217

Occipito-Cervical Fixation Device – Product Status 217

Occipito-Cervical Fixation Device – Product Description 218

Polyaxial Fixation Device – Product Status 218

Polyaxial Fixation Device – Product Description 218

Polyaxial Screw Head – Product Status 219

Polyaxial Screw Head – Product Description 219

Vertebral Body Cage – Product Status 219

Vertebral Body Cage – Product Description 220

University of Toledo Pipeline Products & Ongoing Clinical Trials Overview 221

Anchoring Pedicle Screw – Product Status 221

Anchoring Pedicle Screw – Product Description 222

Bioactive Fusion Device – Product Status 222

Bioactive Fusion Device – Product Description 222

Minimally Invasive Intervertebral Cage – Product Status 223

Minimally Invasive Intervertebral Cage – Product Description 223

Pedicle Screw – Surgical Correction Of Spinal Deformities – Product Status 223

Pedicle Screw – Surgical Correction Of Spinal Deformities – Product Description 224

Retractable Pedicle Screw Assembly – Product Status 224

Retractable Pedicle Screw Assembly – Product Description 224

Self-Expanding Inter-Vertebral Cage – Product Status 225

Self-Expanding Inter-Vertebral Cage – Product Description 225

Shape Memory Alloy Pedicle Screw – Product Status 225

Shape Memory Alloy Pedicle Screw – Product Description 226

Spinal Deformity Correction Device – Product Status 226

Spinal Deformity Correction Device – Product Description 226

Stabilized Spinal Fixation Hook – Product Status 227

Stabilized Spinal Fixation Hook – Product Description 227

Transpedicular Accessing Device – Product Status 227

Transpedicular Accessing Device – Product Description 228

University of Utah Pipeline Products & Ongoing Clinical Trials Overview 229

Wasatch Loop System – Product Status 229

Wasatch Loop System – Product Description 229

University of Virginia Pipeline Products & Ongoing Clinical Trials Overview 230

Spinal Implant – Product Status 230

Spinal Implant – Product Description 230

VersaSpine LLC Pipeline Products & Ongoing Clinical Trials Overview 231

VersaSpine Dual-Ended Pedicle Screw System – Product Status 231

VersaSpine Dual-Ended Pedicle Screw System – Product Description 231

Vertech Inc Pipeline Products & Ongoing Clinical Trials Overview 232

Rotoplasty System – VCF – Product Status 232

Rotoplasty System – VCF – Product Description 232

Verticor (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 233

VClipse Cervical Plating System – Product Status 233

VClipse Cervical Plating System – Product Description 233

VGI Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 234

VerteLX – Product Status 234

VerteLX – Product Description 234

Vivonics Inc Pipeline Products & Ongoing Clinical Trials Overview 235

Midis Cage – Product Status 235

Midis Cage – Product Description 235

White Light Medical Pipeline Products & Ongoing Clinical Trials Overview 236

AccuSpine – Product Status 236

AccuSpine – Product Description 236

Xtremity & Spinal Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 237

FILL AND FIX PEEK OPTIMA ANATOMIC Cervical Cage – Product Status 237

FILL AND FIX PEEK OPTIMA ANATOMIC Cervical Cage – Product Description 237

FILL AND FIX PEEK OPTIMA ANATOMIC Lumbar Cage – Product Status 238

FILL AND FIX PEEK OPTIMA ANATOMIC Lumbar Cage – Product Description 238

Yunyi (Beijing) Medical Device Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 239

3D Printed PEEK Artificial Vertebral Body – Product Status 239

3D Printed PEEK Artificial Vertebral Body – Product Description 239

Zyga Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 240

Glyder Facet Resurfacing System – Product Status 240

Glyder Facet Resurfacing System – Product Description 240

ZygoFix Ltd Pipeline Products & Ongoing Clinical Trials Overview 241

ZLock Cervical Implant – Product Status 241

ZLock Cervical Implant – Product Description 241

ZLock Lumbar Spinal Fusion System – Product Status 242

ZLock Lumbar Spinal Fusion System – Product Description 242

ZLock SI Implant – Product Status 242

ZLock SI Implant – Product Description 243

ZygoFix Ltd – Ongoing Clinical Trials Overview 244

ZLock Lumbar Spinal Fusion System – A Clinical Study to Evaluate the Efficacy of zLOCK Spinal Facet Joint Fixation System in the Treatment of Severe Back and Leg Pain 245

ZLock Lumbar Spinal Fusion System – Safety and Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study 245

ZLock Lumbar Spinal Fusion System – Safety and Efficacy Assessment of Using the zLOCK Facet Stabilization System 245

Glossary 386

Figures

Spinal Fusion – Pipeline Products by Stage of Development 28

Spinal Fusion – Pipeline Products by Segment 29

Spinal Fusion – Pipeline Products by Territory 30

Spinal Fusion – Pipeline Products by Regulatory Path 31

Spinal Fusion – Pipeline Products by Estimated Approval Date 32

Spinal Fusion – Ongoing Clinical Trials 33

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