25 spine devices receive FDA 510(k) clearances in September

Spinal Tech

The Food and Drug Administration granted 25 spine-related clearances in September.

 

1. Ackermann Intervertebral Body Fusion Device from Ackermann Instrumente.

 

2. Bluefin Interbody System from Tides Medical.

 

3. Benefix Interspinous Fixation System from U&I Corporation.

 

4. Hedgehog Cervical Interbody Fusion Device from Vertera.

 

5. CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System from Orthofix.

 

6. LDR Spine RIO-C Cervical Cage System from LDR.

 

7. Genesys Spine Apache Cervical Interbody Fusion System from Genesys Spine.

 

8. NuVasive PEEK Corpectomy System from NuVasive.

 

9. Amendia Interbody Fusion Devices from Amendia.

 

10. NuVasive CoRoent Lumbar System from NuVasive.

 

11. NuVasive PEEK Corpectomy Railed System from NuVasive.

 

12. Gemmed Pedicle Screw Spinal System from Suzhou Gemmed Medical Instrument.

 

13. NuVasive X-CORE Mini Cervical Expandable VBR System from NuVasive.

 

14. Romeo Posterior Osteosynthesis System from Spineart.

 

15. Lotus Posterior Cerivcal/Thoracic Spinal System from Spinal Elements.

 

16. Everest Spinal System from K2M.

 

17. Xenco Medical Pedicle Screw System from Xenco Medical.

 

18. Seneka I Polyscrew Pedicle Fixation System from Seneka Spine.

 

19. Summit SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System from DePuy Synthes.

 

20. Pyrenees Cervical Plate System from K2M.

 

21. Reliance Spinal Screw System from Reliance Medical Systems.

 

22. X-spine Pedicle Screw System from X-Spine Systems.

 

23. Fortress Pedicular Fixation System from Spineology.

 

24. Renovis Anterior Cervical Plate System from Renovis Surgical Technologies.

 

25. Xenco Medical Cervical Interbody System from Xenco Medical.

 

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