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

Spinal Tech

The Food and Drug Administration granted 43 spine and orthopedic device clearances in December.

1. Crystal, Mosaic, Vertu from Spinal Elements.

 

2. G7 Osseoti Acetabular Shells from Biomet.

 

3. Arthrex SutureTak Suture Anchors from Arthrex.

 

4. Juliet LL from Spineart.

 

5. PGS 5.5 MM Cannulated Pedicle Screw from Pinnacle Spine Group.

 

6. Herniatome Percutaneous Discectomy Device from Gallini Medical Devices.

 

7. Zevo Anterior Cervical Plate System from Medtronic Sofamor Danek.

 

8. AcrossSpine Pedicle Screw System from ArthroDif.

 

9. Orthofix Galaxy Wrist from Orthofix.

 

10. Wrist Hemiarthroplasty System from Arthrosurface.

 

11. Orthofix Galaxy Unyco Diaphyseal Tibi Kit from Orthofix SRL.

 

12. GMK Extension from Medacta International.

 

13. Ibis Pedicle Screw System from Ortho Development.

 

14. Bioceptive Suction Cervical Retractor from Bioceptive.

 

15. Valeo C Spacer System, Valeo II C IBF Device from Amedica.

 

16. Interspinous Plate System from Precision Spine.

 

17. Neo Total Knee System from New Era Orthopedics.

 

18. iTotal Posterior Stabilized Knee Replacement System from ConforMIS.

 

19. Mini and Micro Fragments Reconstruction System-NEOFIX from Neoortho Productos Orthopedicos.

 

20. SeaSpine Spacer System from SeaSpine.

 

21. ProxiFuse Hammer Toe Device from Cartiva.

 

22. Alians Ulna Locking Plating System from NewClip Technics.

 

23. Caspian OCT/MESA Mini/DENALI Mini Spinal System from K2M.

 

24. CD Horizon Spinal System says Medtronic Sofamor Danek.

 

25. LITE Plate System from Stryker.

 

26. AIS Odontoid Fracture Fixation System from Aesculap.

 

27. MAS PLIF Fixation System from NuVasive.

 

28. G7 Finned Acetabular Shell from Biomet.

 

29. Zimmer Persona Personalized Knee System from Zimmer.

 

30. Anthem PS Total Knee System from Smith & Nephew.

 

31. Biomet Tibial Trays from Biomet.

 

32. HemiCAP Humeral Head from XL Articular Resurfacing System from Arthrosurface.

 

33. Echo Bi-Metric Microplasty Hip System from Biomet.

 

34. Total Compression Plating System from Wright Medical Technology.

 

35. VLP Mini-Mod Small Bone Plating System 1.5mm Plate and Screws from Smith & Nephew.

 

36. Hemasorbplus Press Resorbable Hemostatic Bone Putty from Orthocon.

 

37. Orthofix True Lok Hexapod System VI. 3 from Orthofix.

 

38. AxSOS 3 Ti Locking Plate System from Stryker Trauma.

 

39. 3.0mm Biomet Cannulated Screw System from Biomet.

 

40. Reform Pedicle Screw System from Precision Spine.

 

41. Threshold Pedicular Fixation System from Spineology.

 

42. Klassic HD Hip System from Total Joint Orthopedics.

 

43. InFill Graft Delivery System from Pinnacle Spine Group.

 

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