24 spine devices receive FDA 510(k) clearance in October

Written by Laura Dyrda | November 06, 2014 | Print  | Email

The Food and Drug Administration granted 24 spine-related 510(k) clearances in October.

1. Genesys Spine Anterior Cervical Plate II System from Genesys Spine.

 

2. Aileron Interspinous Fixation System from Life Spine.

 

3. Innesis PEEK TL Cage from BK Meditech.

 

4. Frontier Devices Fusio Screw Fuze System from Folsom Metal Products.

 

5. Uniever Disposable Spinal Anesthesia Needle from Unisis.

 

6. Freedom Spinal Cord Stimulator System from Stimwave Technologies.

 

7. CD Horizon Spinal System from Medtronic Sofamor Danek.

 

8. Biomet Fusion System from Biomet Spine.

 

9. FloSpine Pedicle Screw System from FloSpine.

 

10. Endoskeleton from Titan Spine.

 

11. SpineFrontier Arena-C HA PEEK Cervical Intervertebral Body Fusion Device from SpineFrontier.

 

12. NuVasive Coroent Small Contoured Interbody System from NuVasive.

 

13. Universal Clamp Spinal Fixation System from Zimmer Spine.

 

14. StaLIF CTI, StaLIF C from Centinel Spine.

 

15. Renovis S134 Anterior Lumbar Interbody Fusion System from Renovis Surgical Technologies.

 

16. Abacus Spacer System from Spine Wave.

 

17. XIA 4.5 Spinal System from Stryker.

 

18. Cogent MED-LIF XL from Cogent Spine.

 

19. Juliet PO from Spineart.

 

20. Xia 3 Spinal System from Stryker.

 

21.Divervence Anterior Cervical Fusion System from Medtronic Sofamor Danek.

 

22. Expedium Spine System/Synapse System from Johnson & Johnson.

 

23. Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL from Titan Spine.

 

24. AIS ModuLIFT VBR System from Aesculap Implant System.

 

More articles on orthopedic devices:
Amedica files IPO registration statement — 5 things to know
Wright Medical-Tornier merger—Can they compete with Zimmer & DePuy Synthes in extremities?
Symmetry Medical makes next move to sell OEM business

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