45 orthopedic, spine devices receive FDA 510(k) clearance in May 2015

Laura Dyrda -   Print  |

The Food and Drug Administration cleared 45 orthopedic- and spine-related devices in May.

1. Pyrenees Cervical Plate System from K2M.

 

2. Chesapeake Stabilization System from K2M.

 

3. SpineFrontier Lumbar Interbody Fusion Device System from SpineFrontier.

 

4. Captiva Spine FuselOX Cervical IBF System from Captiva Spine.

 

5. SpineDesign Spine Surgery Planning from Medtronic Sofamor Danek.

 

6. BioFoam Bone Wedge from Wright Medical.

 

7. Medacta-C TiPEEK from Medacta.

 

8. Azure Anterior Cervical Plate System from Orthofix.

 

9. Rebel 3DKnee System from Encore Medical.

 

10. SMR Modular Glenoid from Lima Corporate.

 

11. Stryker Footed Attachments and Cutting Accessories from Stryker.

 

12. Piccolo Composite Plate System from CaroFix Orthopedics.

 

13. Stryker MIS Attachments and Cutting Accessories from Stryker.

 

14. Renovis Surgical Hip Replacement System from Renovis Surgical Technologies.

 

15. Milagro/Milagro Advance Interference Screw from DePuy Mitek.

 

16. APEX-DL Spine System from SpineCraft.

 

17. Battalion Universal Spacer System from Alphatec Spine.

 

18. Jazz System from Implanet.

 

19. Modified Bencox Hip System from Corentec.

 

20. Blue Mountain Cervical Plate System from SpineWay.

 

21. Lucent; Lucent TI-Bond Systems from Spinal Elements.

 

22. Zimmer Persona Personalized Knee System from Zimmer.

 

23. Life Spine Cannulated Screws from Life Spine.

 

24. Ascendant Cervical Spacer System from Exactech.

 

25. The Octane Straight Intervertebral Fusion Device, Ti Coated from Exactech.

 

26. Mont Blanc Spinal System from SpineWay.

 

27. Subtalar Spacer System from Wright Medical Technology.

 

28. Astra Spine System from SpineCraft.

 

29. JuggerStitch Meniscal Repair Device from Biomet.

 

30. Exactech Equinoxe Reverse Shoulder 46x21 mm from Exactech.

 

31. CalcaNail Orthopedic Nail from Fournitures Hospitalieres Industries.

 

32. CalcaNail Orthopedic Arthrodesis Nail from Fournitures Hospitalieres Industries.

 

33. Interbody Fusion/Vertebral Body Replacement System from RTI Surgical.

 

34. G7 Dual Mobility System from Biomet.

 

35. Oasys System from Stryker.

 

36. Columbus Total Knee System, Columbus Revision Knee System from EnduRo Knee System from Aesculap Implant Systems.

 

37. Response 5.5/6.0 Spine System from Orthopediatrics.

 

38. Rush Medullary Pins from Zimmer.

 

39. Dorsal Spanning Plate from Skeletal Dynamics.

 

40. Versa-Fx Femoral Fixation System from Zimmer.

 

41. Centurion POCT System from Orthofix.

 

42. MAGEC 2 Spinal Bracing and Distraction System from Ellipse Technologies.

 

43. Exactech Optetrak Logic CC from Exactech.

 

44. Elite L Expandable Lumbar Fusion System from Innova Spinal Technologies.

 

45. Arthrex RetroFusion Screw from Arthrex.

 

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