43 orthopedic, spine devices receive FDA 510(k) clearance in March

Spinal Tech

The Food and Drug Administration granted 43 orthopedic- and spine-related device clearances in March.

1. MAGEC Spinal Bracing and Distraction System from Ellipse Technologies.

 

2. DePuy Synthes Injectable Polymer System from DePuy Synthes.

 

3. Proximal Humerus Plating System from Miami Device Solutions.

 

4. DePuy Synthes Variable Angle Locking Hand System from Synthes USA.

 

5. NuVasive CoRoent System from NuVasive.

 

6. Infinity Total Ankle System; InBone Total Ankle System from Wright Medical Technology.

 

7. Ideal Locking Plate System from Jiangsu Ideal Medical Science & Technology.

 

8. Invision Total Ankle Revision System from Wright Medical Technology.

 

9. Nerve Monitoring Cable System from Pioneer Surgical Technology.

 

10. F1-Modular Pedicle Screw System from Degen Medical.

 

11. Biomet Spine Fusion System from Biomet Spine.

 

12. Progressive Orthopedic Total Knee System from The Progressive Orthopaedic Company.

 

13. Arrow Reverse Shoulder long keel and short keel glenoid base from Fournitures Hospitalieres Industries.

 

14. PASS LP Spinal System from Medicrea.

 

15. SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA from Smith & Nephew.

 

16. Xenco Medical Lumbar Interbody System from Xenco Medical.

 

17. Herbert/Whipple Bone Screw System from Zimmer.

 

18. Stryker CMF MEDPOR Customized Implant from Stryker.

 

19. Evolve UniPolar Head from Signature Orthopaedics.

 

20. LnK Anterior Cervical Plate System from L&K Biomed.

 

21. Zimmer Plates and Screws System — Non-sterile ZPS from Zimmer.

 

22. Eminent Foot Plate System from Eminent Spine.

 

23. Affix IIS Spinous Process Plate System from NuVasive.

 

24. VEGA Knee System, Columbus Total Knee System from Aesculap Implants System.

 

25. Mpact Double Mobility System from Medacta.

 

26. Short SureLock All-Suture Anchor from Cayenne Medical.

 

27. Simpliciti Shoulder System from Tornier.

 

28. AccuLIF TL and PL Cage from Stryker.

 

29. inVizia Anterior Cervical Plate System from Zimmer Spine.

 

30. NuVasive NVM5 System from NuVasive.

 

31. Navio from Blue Belt Technologies.

 

32. Biomet Proximal Humerus Plating System from Biomet.

 

33. Consensus Knee System Modular Tibial Baseplate from Consensus Orthopedics.

 

34. Salvation External Fixation System from Wright Medical Technology.

 

35. DePuy Synthes Variable Angle Locking Hand System from Synthes USA.

 

36. Leva Spacer System from Spine Wave.

 

37. Extremity Medical Calcaneal Osteotomy Device from Extremity Medical.

 

38. Range/Denali/Mesa Spinal System from K2M.

 

39. Tarsa-Link Wedge Fixation System from Life Spine.

 

40. Nautilus Spinal System from Life Spine.

 

41. Restoris Porous Partial Knee System from MAKO Surgical.

 

42. LITe Plate System from Stryker.

 

43. Integra Laminoplasty System from SeaSpine.

 

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