29 orthopedic devices receive FDA 510(k) clearance in October

Spinal Tech

The FDA granted 29 orthopedic and spine related clearances in October.

 

1. Arthrex Tenodesis Button from Arthrex.

2. Republic Spine Restore Intervertebral Body Fusion System from Republic Spine.

3. SPIRA Open Matrix ALIF and LLIF from Camber Spine Technologies.

4. 4 CIS PEEK PLIF Cage from Solco Biomedical.

5. AccelFix Lumbar Interbody Fusion Cage System from L&K Biomed.

6. Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set from Medtronic Sofamor Danek.

7. CrossOver Cross Connectors, DePuy Pulse Thoracolumbar Screw System from Medos International.

8. Hedron Cervical Spacers from Globus Medical.

9. iNSitu Bipolar Hip System from Theken Companies.

10. MectaLock Ti Suture Anchor from Medacta International.

11. Precice System from NuVasive.

12. Ti3Z Cervical Interbody System from Zavation Medical Products.

13. Hedron Lumbar Spacers from Globus Medical.

14. JuggerStitch Meniscal Repair Device from Biomet.

15. NuVasive ACP System from NuVasive.

16. Ali Interbody Fusion System from Raed M. Ali, MD.

17. Mercury Spinal System, Overwatch Spinal System from Spinal Elements.

18. Persona Revision Knee System from Zimmer.

19. Genesys Spine Sacroiliac Joint Fusion System from Genesys Spine.

20. OMNI TiN Coated Apex Knee System from OMNI Life Science.

21. TranS1 Interbody Fusion System from TranS1.

22. Catalyst OrthoScience CSR Shoulder System from Catalyst OrthoScience.

23. Aptus Wrist Spanning Plates 2.5 from Medartis.

24. Hinged Laminoplasty System from Life Spine.

25. Mako Total Hip Application from Mako Surgical.

26. Cartiva SCI instrumentation set from Cartiva.

27. NCB Plating System Distal Femur and Proximal Tibia from Zimmer.

28. Innovasis Gibralt Spine System from Inovasis.

29. NuVasive NuvaLine from NuVasive.

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