21 spine devices receive FDA 510(k) clearance in December

Laura Dyrda -   Print  |

The Food and Drug Administration cleared 21 spine-related devices in December 2015.

1. Spinal Inner Fixation System from Changzhou Dingjian Medical Application.

 

2. FIREFLY Pedicel Screw Navigation Guide from Mighty Oak Medical.

 

3. ROSA Brain from Medtech.

 

4. Sahara Stabilization System from K2M.

 

5. Latitude-C Cervical Interbody Spacer System from Degen Medical.

 

6. VariLift-L Interbody Fusion Device from Wenzel Spine.

 

7. RIO-C Titanium-Coated Implant System from LDR Spine.

 

8. PCT System from Centinel Spine.

 

9. Zero-P Natural Plate from Synthes.

 

10. Twin Peaks Lumbar Interbody Fusion System from SpineWay.

 

11. Precice Trauma Nail System from Ellipse Technologies.

 

12. Rectangular Corpectomy Cage from Amendia.

 

13. TOMCAT Cervical Spinal System from Choice Spine.

 

14. Aero-C Cervical Cage System from Stryker Spine.

 

15. XIA 4.5 Spinal Fixation System, Power Adaptor Instrument Accessory from Stryker.

 

16. AccuLIF TL and PL Cage from Stryker.

 

17. NuVasive Foundation-LL System from NuVasive.

 

18. Arsenal Spinal Fixation System from Alphatec Spine.

 

19. Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System from Xenco.

 

20. Endoskeleton TCS System from Titan Spine.

 

21. CD Horizon Spinal System from Medtronic Sofamor Danek.

 

More articles on FDA clearances:
13 spine devices receive FDA 510(k) clearances in November
18 spine devices receives FDA 510(k) clearance in October
25 spine devices receive FDA 510(k) clearance in September

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