32 orthopedic devices receive FDA 510(k) clearance in February

Laura Dyrda -   Print  |

The FDA granted 510(k) clearance to 32 orthopedic devices last month.

1. Comus Locking Plate Systems from Jiangsu Trauhui Medical Instruments.

2. DePuy Synthes Hammertoe Continuous Compression Implant from Synthes Products.

3. Atlas Spine Expandable Cervical Standalone Interbody System from Atlas Spine.

4. Pitkar Locked Plating System from S H Pitkar Orthotools.

5. Zimmer M/L Taper Hip Prosthesis.

6. Glenoid Baseplate with Screw from FX Shoulder USA.

7. Delta Xtend Reverse Shoulder System from DePuy.

8. Exactech Equinoxe Reverse Shoulder Glenospheres from Exactech.

9. Mako Total Hip Application from Mako Surgical Corp.

10. Yukon OCT Spinal System from Stryker.

11. Arthrex Mini Comprehensive Fixation System – 1.0mm Screws from Arthrex.

12. MectaFix CL Fixation Button with Continuous Loop from Medacta International.

13. Alliance Augmented Glenoid from Zimmer.

14. Mojave Expandable Interbody System from Stryker.

15. Daytona Small Stature Growth Rod Conversion Set from SeaSpine Orthopedics.

16. Dunamis PunchTac Suture Anchors from Dunamis.

17. Largo PEEK Interbody System from FloSpine.

18. T2 Alpha Tibia Nailing System, IMN Screw System from Stryker Trauma.

19. KMTI Teresa SA Anterior Lumbar Interbody Fusion System form Kyocera.

20. Perla TL Posterior Osteosynthesis System from Spineart.

21. Summit DuoFix HA Coating from DePuy Orthopaedics.

22. Nexxt Matrixx System from Nexxt Spine.

23. Trigon HA Stand-Alone Wedge Fixation System from Nvision Biomdical Technologies.

24. Titanium Interference Screws from Biomet.

25. MectaLock All-Suture Anchors from Medacta International.

26. OrthoCircle Spine Pedicle Screw System from OrthoCircle Spine.

27. NuVasive X-Core Expandable VBR System from NuVasive.

28. Steerable Plateau Ti from Life Spine.

29. WIN Flexible Nail System from Biomet.

30. Aptus Forearm Shaft Plates and Aptus Wrist 2.5 System from Medartis.

31. SpineNet SSP System from SpineNet.

32. Daytona Small Stature Spinal System from SeaSpine Orthopedics.

More articles on devices:
5 orthopedic expansion projects costing $200M+
5 recent telemedicine developments for spine, orthopedics
Dr. Scott Boden: Telemedicine can achieve spine success if 'reimbursement barriers are reduced'

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