42 orthopedic devices receive FDA clearance in October


The Food and Drug Administration granted 42 orthopedic-related 510(k) clearances in October.

1. Vital Spinal Fixation System from ZimVie Spine.

2. Tornier Humeral Nail and Tornier Long Humeral Nail from Tornier.

3. Acro Composites Interbody System from Acro Composites.

4. Exactech Vantage Total Ankle System from Exactech.

5. Zeus Spinal System from Shanghai Sanyou Medical Co.

6. Pearla TL Posterior Thoracolumbar Fixation System from Spineart.

7. All-Suture Anchor from Riverpoint Medical.

8. Stable-L Standalone Lumbar Interbody System from Nexus Spine.

9. CoreLink Robotic Navigation Instruments from CoreLink.

10. Veos Spinal Fixation System from Spineway.

11. Pro-Link & Pro-Link Ti Barbs Cervical Spacer System from Life Spine.

12. Anax 5.5 Spinal System from Innosys.

13. VyLink Spinal Screw System from Vy Spine.

14. OptiMesh Multiplanar Expandable Interbody Fusion System from Spineology.

15. Momentum Posterior Spinal Fixation System with G21 V-Steady Bone Cement from Ulrich 16. Medical USA.

17. ClariVy Cervical IBF System from Vy Spine.

18. SpineEOS from EOS imaging.

19. MedactaLIF Anterior Lag Extension from Medacta International.

20. Ascend VBR System, Ascend NanoTec VBR System from Alphatec Spine.

21. Reunion Sacroiliac Joint Fusion System from Astura Medical.

22. Victory Lumbar Plate System from Globus Medical.

23. CarboClear Pedicle Screw System from Carbofix Orthopedics.

24. Rigel 3DR Standalone Anterior Cervical Interbody Fusion System from MiRus.

25. Actinia hip stems from Implantcast.

26. Vy Spine VyLam Laminoplasty System from Vy Spine.

27. Rigel 3DR Anterior Cervical Corpectomy System from MiRus.

28. KeyLift Expandable Interlaminar Stabilization System from FloSpine.

29. 2.7 MM Gryphon Flex Knotless PEEK Anchor from Medos International.

30. Calibrate CCX Interbody System from Alphatec Spine.

31. Ripley Spinal Screw System by Sagico from Sagico.

32. Rexious Spinal Fixation System, Statera Spinal System, from K&J Consulting Corp.

33. Knotilus+ PEEK Knotless Anchor from Stryker Endoscopy.

34. Arthrex FiberTape and TigerTape Cerclage Sutures from Arthrex.

35. Peridot-TD Spacer System from GBS Commonwealth.

36. Arthrex Small External Fixation System from Arthrex.

37. Balanced Knee System TriMax PS Plus Tibial Insert from Ortho Development Corp.

38. OGmend Implant Enhancement System from Woven Orthopedic Technologies.

39. Emphasys Femoral Stems from DePuy Ireland.

40. PressON Spinal Fixation System from Nexus Spine.

41. Solace Sacroiliac Fixation System from Xenix Medical.

42. Shadow Knotless All-Suture anchors from Responsive Arthroscopy.


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