37 spine, orthopedic devices receive FDA 510(k) clearance in September

Orthopedic

The Food and Drug Administration cleared 37 orthopedic- and spine-related devices in September.


1. Clydesdale Spinal System from Medtronic.

2. Longbow Spacer System from Life Spine.

3. Genesys Spine Anterior Buttress Plate System from Genesys Spine.

4. General Spinal System from Changzhou Dean Medical Instrument.

5. Renaissance X System from Mazor Robotics.

6. Forticore from Nanovis.

7. Titanium Versa-Dial Humeral Head Prosthesis from Biomet.

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

9. Biomet Graft Delivery Syringes from Biomet Spine.

10. Xenco Medical Cervical Interbody System from Xenco Medical.

11. Orthofix TL-HEX True LOK Hexalobe System from Orthofix.

12. Intramedullary Nail and Screws-NeoNail from NeoOrtho Productos Ortopedicos.

13. Profemur Renaissance Classic Long Neck Hip Stems from MicroPort Orthopedics.

14. Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation from Spineart.

15. Arena-C from SpineFrontier.

16. Renovis Cemented Hip System from Renovis Surgical Technologies.

17. Mobis II ST Spinal Implant from Signus Medizintechnik GMBH.

18. Optio-C Anterior Cervical System from Zimmer Spine.

19. Iassist Knee System from Zimmer.

20. Arthrex iBalance TKA System from Arthrex.

21. Polaris Spinal System – HA Coated from Biomet Spine.

22. Mastergraft Matrix EXT; Mastergraft Putty, Mastergraft Strip from Medtronic Sofamor Danek.

23. Romeo Posterior Osteosynthesis System from Prebent Cross-Connectors; Prebent Rods from Spineart.

24. Trabecular Metal Tibial Cone Broach, Trabecular Metal Coupled Tibial Cone Broach from Zimmer.

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

26. Synapse System, Synthes OC Fusion System from Synthes USA.

27. Pro-Link Wedge System from Life Spine.

28. Stryker S2 Drill from Stryker.

29. Cortical Screw 2.5, T15, Self-Tapping, Titanium, Cortical Screw 3.5, T25, Self-Tapping, Titanium from aap Implantate.

30. 4Web Spinal Implant Products from 4Web.

32. C-Wire Double Ended Orthopedic Wires from Conmed.

33. Via Spinous Process Fixation System from Spineology.

34. Apollo Suture Anchor System and Titan Screws from Valeris Medical.

35. Sirius Femoral Stem, Size 30A from Biomet.

36. Flower Upper Extremity Plating Set from Flower Orthopedics.

37. Hemasorb Resorbable Hemostatic Bone Putty from ORTHOCON.

 

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