20 spine devices receive FDA 510(k) clearance in November

Spinal Tech

The Food and Drug Administration granted 20 spine-related device clearances in November.

1. Maxan Anterior Cervical Plate System from Biomet Spine.

 

2. Opticage Expandable Interbody Fusion Device from Intervertebral Spine.

 

3. Pass LP Spinal System from Medicrea.

 

4. Zip MIS Interspinous Fusion System from Aurora Spine.

 

5. Arena-C TiFuse Cervical Intervertebral Body Fusion Device from SpineFrontier.

 

6. C2 Spinal Fixation System from SpineSmith.

 

7. CoRoent System from NuVasive.

 

8. NuVasive NVM5 System from NuVasive.

 

9. Capri from K2M.

 

10. Luna Interbody System from Benvenue Medical.

 

11. Transom Anterior Cervical Plate from Neurostructures.

 

12. Aero-LL Lumbar Cage System from Stryker.

 

13. Expedium Verse Spine System from DePuy Spine.

 

14. LessRay with Tracking from SafeRay Spine.

 

15. AVS AS PEEK Spacer from Stryker.

 

16. KangLif Pedicle Screw Spinal System from Suzhou Kangli Orthopaedics Instruments.

 

17. CoRoent Small Interlock System from NuVasive.

 

18. Amedica Valeo II Interbody Fusion Device from Amedica.

 

19. Reline Spine from NuVasive.

 

20. Vertical Expandable Prosthetic Titanium Rib from DePuy Synthes Spine.

 

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