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

Spinal Tech

The FDA cleared 29 orthopedic and spine devices in November 2018.


1. DePuy Synthes Trauma Orthopedic Plates and Screws from Synthes Products/DePuy.

2. NuVasive Reline Fenestrated Screws, High V+ Bone Cement from NuVasive.

3. DePuy Synthes 2.0 mm Quick Insertion Screws from Synthes USA Products.

4. NuVasive Monolith Cervical Corpectomy System from NuVasive.

5. Responsive Arthroscopy Interference Screw System from Responsive Arthroscopy.

6. Santorini Corpectomy Cage System, CAPRI Corpectomy Cage System from K2M.

7. Panta 2 Arthrodesis Nail System from Integra Lifesciences Corp.

8. SMS Femoral Stem from Medacta.

9. Velofix TLIF Cage of U&I Corp.

10. Spinal Elements Ti-Bond coated devices from Spinal Elements.

11. Assure Anterior Cervical Plate System, Providence Anterior Cervical Plate System, VIP Anterior Cervical Plate System, Citadel Anterior Lumbar Plate System, Truss Thoracolumbar Plate System, Plymouth Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, Relieve Laminoplasty Fixation System from Globus Medical.

12. Brainlab Compatible K2M Navigation Instruments from K2M.

13. ostaPek Interbody Fusion Cages from cologne.

14. Mazor X system (Mazor X Stealth Edition) from Mazor Robotics.

15. CD Horizon Spinal System Instruments for use with Mazor X Stealth Edition from Mazor Sofamor Danek.

16. PathLoc-L MIS Spinal System from L&K Biomed.

17. Yukon OCT Spinal System from K2M.

18. Arco-SA Lumbar Cage System from NeuroStructures.

19. Stratum Foot Plating System from Nextremity Solutions.

20. V3 Segemental Plating System from Atlas Spine.

21. Exactech Alteon Highly Polished Femoral Stem from Exactech.

22. Plateau Spacer System from Life Spine.

23. Saxxony Posterior Cervical Thoracic System from Nexxt Spine.

24. VersaLink Fixation System from Premia Spine.

25. ATEC ALIF and LLIF Spacer System from Alphatec Spine.

26. Aspida Anterior Lumbar Plating System from Alphatec Spine.

27. Prodense Bone Graft Substitute from Wright Medical Technology.

28. iFuse Implant System from SI-BONE.

29. Smith & Nephew Visionaire Patient Matched Cutting Blocks from Smith & Nephew.

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