36 orthopedic devices receive FDA 510(k) clearance in March

Spinal Tech

The FDA cleared 36 orthopedic devices in March.

1. Ossiofiber Hammertoe Fixation System and Implant from Ossio.

2. KinematX Total Wrist Arthroplasty System from Extremity Medical.

3. Megafix Pedicle Screw Spinal System from SeohanCare.

4. CPT Hip System from Zimmer.

5. Capstone Spinal System, Clydesdale PTC Spinal System, Crescent Spinal System from Medtronic Sofamor Danek.

6. Icotec Cervical Cage from icotec.

7. Mecta-C Stand Alone from Medacta.

8. Medacta Shoulder System from Medacta.

9. Response Spine System from OrthoPediatrics.

10. iUni Unicondylar Knee Replacement System from Conformis.

11. Nano FortiFix System from Nanovis Spine.

12. CarboClear Lumbar Cage System from CarboFix Orthopedics.

13. ALLthread PEEK Suture Anchor from Biomet.

14. SeaSpine Skipjack System from SeaSpine Orthopedics.

15. Tritium Sternal Cable Plate System from Pioneer Surgical Technology.

16. SI-Bone iFuse Implant System from SI-Bone.

17. NuVasive Cohere Thoracolumbar Interbody System from NuVasive.

18. Healicoil Knotless Suture Anchors from Smith & Nephew.

19. Materialise Shoulder Guide and Models form Materialise.

20. NuVasive 3DP Interfixated ALIF System from NuVasive.

21. NorthStar OCT Spinal System from SeaSpine Orthopedics.

22. Arix Ankle System from Jeil Medical.

23. Aptus Ankle Trauma System from Medartis.

24. Aptus Foot 2.8-3.5 System from Medartis.

25. Field Orthopaedics Bony Trauma Extremity System from Field Orthopaedics.

26. MectaLIF Anterior Simple from Medacta International.

27. Response BandLoc Spinal Fixation from OrthoPediatrics.

28. GEO 1st MTP Joint Arthrodesis Plating System from Gramercy Extremity Orthopedics.

29. Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral from Zimmer.

30. Persona Personalized Knee System from Zimmer.

31. SEA-LINK Anterior Cervical Plate System from Indius Medical Technologies.

32. LOSPA IS Spinal Fixation System from Corentec.

33. The Gecko Spinal System from Ortho Development Corporation.

34. Arthrex FiberTak Suture Anchor from Arthrex.

35. iBalance UKA Tibial Tray Implant from Arthrex.

36. Nexxt Matrixx Stand Alone Cervical-Turn Lock System from Nexxt Spine.

 

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