140 spine devices receive FDA 510(k) clearance in 2018 so far

Written by Laura Dyrda | September 05, 2018 | Print  |

The FDA granted 140 spine-related devices 510(k) clearance in 2018 so far.

Here are the devices, listed by month.

January: 16

1. K2M Navigation Instruments from K2M.

2. Stryker iVAS Elite Inflatable Vertebral Augmentation System from Stryker.

3. Matisse Anterior Cervical Interbody Fusion Cage System, Ti-PEEK from CTL Medical.

4. Arbor External Fixation System from Globus Medical.

5. Spineology Navigation Instruments from Spineology.

6. Wiltrom Spinal Fixation System from Wiltrom.

7. TiGer Shark System from ChoiceSpine.

8. ChoiceSpine Laminoplasty Fixation System from ChoiceSpine.

9. Cervical Spinal Truss System Interbody Fusion Device from 4Web.

10. Reliance Lumbar IBF System from Reliance Medical Systems.

11. Navigated Infinity Instruments from Medtronic Sofamor Danek.

12. Titanium TL Curved Posterior Lumber Cage from Stryker.

13. Everest Spinal System from K2M.

14. SeaSpine Cabo Anterior Cervical Plate System from SeaSpine Orthopedics.

15. Juliet Ti LL from Spineart.

16. DeGen Medical E3 MIS Pedicle Screw System from Degen Medical.

February: 15

1. Zyston Strut Open Titanium Spacer System from Zimmer Biomet.

2. Tryptik2 C-Plate Anterior Cervical Plate System from Spineart.

3. The Plateau-LO Spacer System from Life Spine.

4. Cascadia Interbody System from K2M.

5. NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System; NuVasive AP Expandable XLIF System from NuVasive.

6. The Solstice OCT System from Life Spine.

7. Cavetto-SA Cervical Cage System from NeuroStructures.

8. Seurat Universal Pedicle Screw System from CTL Medical Corporation.

9. Alta Anterior Cervical Interbody Spacer from Astura Medical.

10. SeaSpine Spinous Process System from SeaSpine Orthopedics.

11. Endoskeleton TAS Interbody Fusion, Endoskeleton TAS Hyperlordotic Interbody Fusion Device fromTitan Spine.

12. Camber Spine Technologies Spira-V Open Matrix Corpectomy Cage from Camber Spine Technologies.

13. SeaSpine Mariner Pedicle Screw System from SeaSpine Orthopedics.

14. UNiD Spine Analyzer from Medicrea International.

15. SeaSpine NewPort Spinal System from SeaSpine Orthopedics.

March: 15

1. Fortress Radiopaque Bone Cement, Creo Fenestrated Screw System, Revlok Fenestrated Screw System from Globus Medical.

2. Arco-SA Lumbar Cage System from NeuroStructures.

3. Sentio MMG Pedicle Access Needless from Medos International.

4. Mega Plus Spine System from BK Meditech.

5. CD Horizon Spinal System from Medtronic Sofamor Danek.

6. Valeo C+CSC with Lumen Interbody Fusion Device from Amedica.

7. SI Screw System from Zavation Medical Products.

8. Genesys Spine AIS-C Cervical Anchored Interbody System from Genesys Spine.

9. X-spine Cortical Bone Screw System from X-spine Systems.

10. SP-Fix Spinous Process Fixation Plate, Relieve Laminoplasty Fixation System from Globus Medical.

11. NuVasive VuewPoint II OCT System from NuVasive.

12. Polaris Spinal Growth System from Zimmer Biomet Spine.

13. Cortina Lumbar Cage System from NeuroStructures.

14. CapLOX II / TowerLOX MIS Pedicle Screw System from Captiva Spine.

15. Zavation Buttress Plate System from Zavation Medical.

April: 22

1. Reform POCT System from Precision Spine.

2. Half Dome Posterior Lumbar Interbody System from Astura Medical.

3. Mercury Spinal System from Spinal Elements.

4. Unity Sacroiliac Joint Fixation System from Huvexel.

5. Enza-A Titanium ALIF from Camber Spine Technologies.

6. MySpine Pedicle Screw Placement Guides from Medacta International.

7. SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device from SeaSpine.

8. UNiD Patient Specific 3D printed cage from Medicrea International.

9. Axis Anterior Cervical Plate System from Axis Orthopaedics.

10. Genesys Spine Binary Lumbar Plate System from Genesys Spine.

11. Mediant Anterior Cervical Plating System from Intelligent Implant Systems.

12. Rampart One Lumbar Interbody Fusion Device from Spineology.

13. Fibergraft BG Matrix Bone Graft Substitute from Prosidyan.

14. Cure Lumbar Plate System from Meditech Spine.

15. Creo Stabilization System from Globus Medical.

16. Axis 5.5 Lumbar pedicle Screw System from Axis Orthopaedics.

17. Mazor X from Mazor Robotics.

18. Patriot Spinal Fixation System from Valorus Spine.

19. K2M Patient Specific Rods from K2M.

20. Focus Pedicle Screw System from Nvision Biomedical Technologies.

21. Precice Stryde System from NuVasive Specialized Orthopedics.

22. Vertex Reconstruction System from Medtronic Sofamor Danek.

May: 22

1. Icotec Interbody Cage System from icotec ag.
2. A-CIFT SoloFuse from SpineFrontier.

3. SeaSpine Navigation System from SeaSpine Orthopedics.

4. SpineKure Kyphoplasty System from Hanchang.

5. Stalif C FLX from Centinel Spine.

6. Patriot Colonial Spacer, Sustain Spacer from Globus Medical.

7. InTice-C Porous Ti Cervical Interbody System from X-Spine Systems.

8. NuVasive XLX Interbody System from NuVasive.

9. SAGICO OSI Spinal System by Osimplant from Spinal Analytics & Geometrical Implants.

10. Hexanium TLIF from SpineVision.

11. Harrier-SA Lumbar Interbody System from ChoiceSpine.

12. Pro-Link Ti Stand-alone Cervical Spacer System from Life Spine.

13. Arthrex FastThread Interference Screw from Arthrex.

14. SeaSpine Daytona Small Suture Spinal System from SeaSpine Orthopedics.

15. Reliance Lumbar IBF System from Reliance Medical Systems.

16. Kyphon HV-R Bone Cement from Medtronic Sofamor Danek.

17. Spineology Navigation Instruments from Spineology.

18. Aerial Interspinous Fixation from Globus Medical.

19. DTRAX Spinal System from Providence Medical Technology.

20. EVOL Spinal Interbody System from Cutting Edge Spine.
21. Navigated Infinity Instruments from Medtronic Sofamor Danek USA.

22. Everest Spinal System from K2M.

June: 22

1. Icotec Interbody Cage System from icotec.

2. A-CIFT SoloFuse from SpineFrontier.

3. SeaSpine Navigation System from SeaSpine Orthopedics.

4. SpineKure Kyphoplasty System from Hanchang.

5. STALIF C FLX from Centinel Spine.

6. Patriot Colonial Spacer, Sustain Spacer from Globus Medical.

7. InTice-C Porous Ti Cervical Interbody System from X-Spine Systems.

8. NuVasive XLX Interbody System from NuVasive.

9. Stylo Interbody Fusion Device from Legend Spine Technologies.

10. Sagico OSI Spinal System by Osimplant from Spinal Analytics.

11. Hexanium TLIF from SpineVision.

12. Atec Universal Spacer System from Alphatec Spine.

13. Harrier-SA Lumbar Interbody System from ChoiceSpine.

14. Pro-Link Ti Stand-Alone Cervical Spacer System from Life Spine.

15. SeaSpine Daytona Small Stature Spinal System from SeaSpine Orthopedics.

16. Reliance Lumbar IBF System from Reliance Medical Systems.

17. Kyphon HV-R Bone Cement from Medtronic Sofamor Danek.

18. Spineology Navigation Instruments from Spineology.

19. Aerial Interspinous Fixation from Globus Medical.

20. DTRAX Spinal System from Providence Medical Technology.

21. EVOL Spinal Interbody System from Cutting Edge Spine.

22. Everest Spinal System from K2M.

July: 28

1. CarboClear Pedicle Screw System from CarboFix Orthopedics.

2. Jasper Spinal Fixation System from GBS Commonwealth.

3. PEEKplus Interbody Fusion Device from Vallum Corp.

4. Lumbar Interbody Fusion System from Advanced Research Medical.

5. Athena Cervical Plate System from Medyssey USA.

6. Ti 3z Interbody System from Zavation Medical Products.

7. Trend II Spinal Fixation System – STEP Series from Paonan.

8. Corelink Foundation 3D Anterior Lumbar System from Corelink.

9. DePuy Synthes Static Staples from Synthes USA Products.

10. Tyber Medical PT Interbody Spacer System from Tyber Medical.

11. Viking Lumbar Polyaxial Screw System from Presidio Surgical.

12. Normandy VBR System from Zavation Medical.

13. Vail ALIF Buttress Plate System from Evolution Spine.

14. Tritanium PL Cage from Stryker Spine.

15. Rubicon Lumbar Interbody Fusion System from Rubicon Spine.

16. CxHA PEEK Cervical IBF System from Innovasis.

17. Olympic Posterior Spinal Fixation System from Astura Medical.

18. Zavation Cervical Plate System from Zavation Medical.

19. Zavation IBF System from Zavation Medical Products.

20. Curiteva Cervical Interbody Fusion System from Curiteva.

21. Altus Spine Pedicle Screw System from Altus Partners.

22. Astra-OCT Spine System from SpineCraft.

23. Firefly Pedicle Screw Navigation Guide from Mighty Oak Medical.

24. Proficient Posterior Cervical Spine System from Spine Wave.

25. ATEC ALIF Spacer System from Alphatec Spine.

26. Republic Spine Dark Star Spinal System from Republic Spine.

27. Stowe Pedicle Screw System from Black Box Medical.

28. PathLoc-SI Joint Fusion System from L&K Biomed.

More articles on spine devices:
What the $1.4B K2M acquisition could do for Stryker
Zimmer Biomet, DePuy Synthes, Medtronic & more: 15 device company key notes
Aurora Spine achieves record high Q2 revenue: 3 details

 

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