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38 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in December

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The Food and Drug Administration granted 38 orthopedic- and spine-related device clearances in December.
1. Polaris Spinal System—Ballista II Rods from Biomet Spine.

2. Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral Stems from Zimmer.

3. Firebird Spinal Fixation System from Orthofix.

4. Phoenix MIS Spinal Fixation System from Orthofix.

5. Galleon Pedicle Screw Systems from Everest Spine.

6. LessRay from SafeRay Spine.

7. IN:C2 Spinal Fixation System from Spine Smith Partners.

8. Zimmer Persona: The Personalized Knee System from Zimmer.

9. Zimmer Patient Specific Instruments System from Materialise.

10. Exactech Equinoxe Shoulder System Torque Defining Screw and Shoulder Replicator Plate from Exactech.

11. Patriot Spacers from Globus Medical.

12. ES2 Spinal System from Stryker Spine.

13. V2F Anterior Fixation System from Zimmer Spine.

14. NuVasive Bendini Spinal Rod Bending System from NuVasive.

15. Loqteq Proximal Humerus Plate from aap Implantate.

16. Emerge Medical Solid Bone Screws from Emerge Medical.

17. PBP Total Hip System from Pipeline Biomedical Products.

18. Ambient TurboFlash from ArthroCare.

19. Malibu Spinal System With the Daytona Deformity System from SeaSpine.

20. S4 Spinal System from Aesculap Implant Systems.

21. Milagro Interference Screws from DePuy Mitek.

22. Ascendx VCF Reduction System from AIO Medical.

23. Anodyne Anterior Cervical Plate System from CoreLink.

24. VertiFlex Spinous Process Fixation Plate from VertiFlex.

25. Columbus Total Knee System from Aesculap Implant Systems.

26. Synthes Navigable Pedicle Preparation Instruments from Synthes Spine.

27. GKS Prime Flex CR Total Knee System from Permedica.

28. iTotal Cruciate Retaining Knee Replacement System from ConforMIS.

29. Stablink MIS Spinal Fixation System from Southern Spine.

30. Delta TT Cups, Liners, Bone Screws from LimaCorporate.

31. UltraQuik Peripheral Nerve Block Needle from Arrow International.

32. Kyphon Express II Inflatable Bone Tamps from Medtronic.

33. Integra Total Foot Systems from Integra LifeSciences.

34. Arthrex Pec Repair Button from Arthrex.

35. A-Wedge Anterior Interbody System from Sapphire Medical Group.

36. Flexlite Camera from Spine View.

37. Origin Hip Stem, Femoral Head from Signature Orthopaedics.

38. DePuy Pulse Anterior Cervical In-Line Plate System from Medos International.


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