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

Spinal Tech

The Food and Drug Administration granted 45 orthopedic- and spine-related device clearances in April.

1. Sustain TPS Spacers, Patriot TPS Spacers, Caliber TPS Spacer, Coalition TPS Spacers, Independence TPS Spacer, Fortify-R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer from Globus Medical.

 

2. Verasense Knee System from OrthoSensor.

 

3. Arthrex Univers Revers CA Heads and Adapters from Arthrex.

 

4. Diplomat Spinal System from Signus Medizintechnik.

 

5. icotec Pedicle System from Icotec AG.

 

6. KLS Martin LSS Plating System from KLS Martin.

 

7. Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug from Corentec.

 

8. All Poly Tibial Component from United Orthopedic Corporation.

 

9. HemiCAP MTP Resurfacing Hemi-Arthroplasty System from ArthroSurface.

 

10. Revival Modular Revision Hip Stem from Corin USA.

 

11. Genesys Spine Apache Interbody Fusion System from Genesys Spine.

 

12. Syzyqy Stabilization System from Amendia.

 

13. Leva Spacer System from Spine Wave.

 

14. Hoffman Limb Reconstruction Frame System from Stryker.

 

15. Zavation Spinal System from Zavation.

 

16. PASS LP Spinal System from Medicrea.

 

17. NuVasive CoRoent Thoracolumbar System from NuVasive.

 

18. Olympic Posterior Spinal Fixation System from Astura Medical.

 

19. Inertia Pedicle Screw and Deformity Correxxion System from Nexxt Spine.

 

20. KLS Martin Thoracic Plating System from KLS-Martin.

 

21. Pyrenees Cervical Plate System from K2M.

 

22. Ventix Suture Anchor from Biomet.

 

23. Materialise Glenoid Positioning System from Materialise.

 

24. Alphatec Navigation Instruments from Alphatec Spine.

 

25. First Ray Internal Bone Staple System from First Ray.

 

26. Bicortical Fixation Screw & Washer Nut System from First Ray.

 

27. Chattanooga Revolution Wireless DJO.

 

28. LumenR Tissue Retractor System from LumenR.

 

29. SMR 3-Pegs Glenoids from Lima Corporate.

 

30. NuVasive Interfixated Interbody System from NuVasive.

 

31. LUMIS Cannulated Pedicle Screw Fixation System from U.L.I.S. Pedicle Screw Fixation System.

 

32. Cascadia Interbody System from K2M.

 

33. Gridlock Ankle Plating System from Trilliant Surgical.

 

34. Revolution Spinal Fixation System from Intelligent Implant Systems.

 

35. Iconacy I-Hip from Iconacy Orthopedic Implants.

 

36. OsteoBullet Compression Screw from Phalanx Innovations.

 

37. Premier from Shandong Weigao Orthopaedic Device.

 

38. Precice Intramedullary Limb Lengthening System from Ellipse Technologies.

 

39. spineEOS from OneFit Medical.

 

40. Arthrex iBalance BiCompartmental Arthroplasty System from Arthrex.

 

41. Opticage Expandable Interbody Fusion Device from Interventional Spine.

 

42. White Pearl Preferred Angle Anterior Cervical Plate from Osseus Fusion Systems.

 

43. G3 Active Plate Small Fragment System from Genesis Fracture Care.

 

44. PASS OCT Spinal System from Medicrea.

 

45. Denali Filter System – Femoral Delivery Kit, Denali Filter System – Jugular/Subclavian Delivery Kit from C.R. Bard.

 

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