22 spine devices receive FDA 510(k) clearance in May

Spinal Tech

The Food and Drug Administration cleared 22 and spine-related devices in May.

1. Pyrenees Cervical Plate System from K2M.

 

2. Chesapeake Stabilization System from K2M.

 

3. SpineFrontier Lumbar Interbody Fusion Device System from SpineFrontier.

 

4. Captiva Spine FuseLOX Cervical IBF System from Captiva Spine.

 

5. SpineDesign Spine Surgery Planning from Medtronic Sofamor Danek.

 

6. Mecta-C TiPEEK from Medacta.

 

7. Azure Anterior Cervical Plate System from Orthofix.

 

8. APEX-DL Spine System from SpineCraft.

 

9. Battalion Universal Spacer System from Alphatec Spine.

 

10. Jazz System from Implanet.

 

11. Blue Mountain Cervical Plate System from SpineWay.

 

12. Lucent; Lucent TI-Bond Systems from Spinal Elements.

 

13. Life Spine Cannulated Screws from Life Spine.

 

14. Ascendant Cervical Spacer System from Exactech.

 

15. The Octane Straight Intervertebral Fusion Device, Ti Coated from Exactech.

 

16. Mont Blanc Spinal System from SpineWay.

 

17. Astra Spine System from SpineCraft.

 

18. Interbody Fusion/Vertebral Body Replacement System from RTI Surgical.

 

19. Oasys System from Stryker.

 

20. Response 5.5/6.0 Spine System from Orthopediatrics.

 

21. MAGEC 2 Spinal Bracing and Distraction System from Ellipse Technologies.

 

22. Elite L Expandable Lumbar Fusion System from Innova Spinal Technologies.

 

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