26 Spine Devices Receive FDA 510(k) Clearance in December Featured

The Food and Drug Administration granted 26 spine-related 510(k) clearances in December, according to an FDA report.

1. Acculif TL-PEEK IBF Cage from Coalign Innovations.

2. Renaissance System from Mazor Robotics.

3. Axle PEEK Interspinous Fusion System from X-Spine Systems.

4. Athena Pedicle Screw System from Royal Oak Medical Devices.

5. Shield Kyphoplasty System from Soteira.

6. VariLIFT Cervical Interbody Fusion System from Wenzel Spine.

7. Zavation Cervical Plate System from Zavation.

8. Genesys Spine Anterior Cervical Plate System from Genesys Spine.

9. SI-Lok Sacroiliac Joint Fixation System from Globus Medical.

10. Xingtm Spine System from Implanova.

11. Synthes Zero-P from Synthes Spine.

12. VBB System from Synthes.

13. Cougar System from Johnson & Johnson.

14. Staxx XD System from SpineWave.

15. 4-Web ALIF Spinal Truss System from 4-Web.

16. Lancer Pedicle Screw System from Spinal Solutions.

17. Lanx Cervical SA from Lanx.

18. Spotlight Access System from Johnson & Johnson.

19. Lanx Posterior Cervicothoracic Spinal Fixation System from Lanx.

20. Clydesdale Spinal System from Medtronic Sofamor Danek.

21. Range Spinal System (Mesa and Denali) from K2M.

22. Synthes MIRS from Synthes Spine.

23. Pencan Spinal Needle from B. Braun Medical.

24. Confidence High Viscosity Spinal Cement from Medos International.

25. Zavation IBF Systems from Zavation.

26. SeaSpine Monopolar Probe System from SeaSpine.


Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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