40 spine, orthopedic device receive FDA 510(k) clearance in October

The Food and Drug Administration granted 40 spine- and orthopedic-related device clearances in October.

1. Genesys Spine Anterior Cervical Plate II System from Genesys Spine.

2. Aileron Interspinous Fixation System from Life Spine.

3. Integra External Fixation System from Ascension Orthopedic.

4. Innesis PEEK TL Cage from BK Meditech.

5. Juggerknot Mini Soft Anchor from Biomet Sports Medicine.

6. Frontier Devices Fusio Screw Fuze System from Folsom Metal Products.

7. Uniever Disposable Spinal Anesthesia Needle from Unisis.

8. Biomet Orthopaedic Salvage System from Biomet.

9. Freedom Spinal Cord Stimulator System from Stimwave Technologies.

10. Vanguard XP Femoral Component/Vanguard XP Femoral Trial from Biomet.

11. CD Horizon Spinal System from Medtronic Sofamor Danek.

12. Pro-Toe X-flex Hammertoe fixation system from Wright Medical Technology.

13. Residual Limb Lengthening System from Ellipse Technologies.

14. Biomet Fusion System from Biomet Spine.

15. FloSpine Pedicle Screw System from FloSpine.

16. Starband, Starlight from Orthomerica Products.

17. AOS Small Bone External Fixation from Advanced Orthopaedic Solutions.

18. SpineMask Tracker from Stryker.

19. Endoskeleton from Titan Spine.

20. Klassic HD Acetabular Insert With E-Link Poly from Total Joint Orthopedics.

21. SpineFrontier Arena-C HA PEEK Cervical Intervertebral Body Fusion Device from SpineFrontier.

22. NuVasive Coroent Small Contoured Interbody System from NuVasive.

23. Universal Clamp Spinal Fixation System from Zimmer Spine.

24. STALIF CTI, STALIF C from Centinel Spine.

25. Renovis S134 Anterior Lumbar Interbody Fusion System from Renovis Surgical Technologies.

26. Rebossis from ORTHOREBIRTH.

27. Abacus Spacer System from Spine Wave.

28. XIA 4.5 Spinal System from Stryker.

29. AIS ModuLIFT VBR System from Aesculap Implant System.

30. Cogent MED-LIF XL from Cogent Spine.

31. Juliet PO Spineart.

32. Zimmer M/DN Intramedullary Fixation System from Zimmer.

33. Xia 3 Spinal System from Stryker.

34. Magna-FX and MINI Magna-FX Cannulated Screw Fixation System from Zimmer.

35. Divervence Anterior Cervical Fusion System from Medtronic Sofamor Danek.

36. Expedium Spine System/Synapse System from Johnson & Johnson.

37. 4.5mm Healix Ti Anchor, with two or three strands of #2 Permacord suture from DePuy Mitek.

38. Zimmer Periarticular Plating System from Zimmer.

39. Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL from Titan Spine.

40. Valor Hindfoot Fusion Nail System from Wright Medical Technology.

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Webinars

Featured Whitepapers

Featured Podcast