22 spine devices receive FDA 510(k) clearance in November 2016

Spinal Tech

FDA clears 22 spine-related devices in November 2016.

1. PathLoc-SI Joint Fusion System from L&K Biomed.

2. Lumbar Interbody Fusion System from Evolution Spine.

 

3. Amendia Interbody Fusion Devices from Amendia.

4. Xert Lumbar Expandable Interbody System from X-Spine Systems.

 

5. Genesys Spine Apache Anterior Lumbar Interbody Fusion System from Genesys Spine.

 

6. Virtu C Spine Implant System from Met 1 Technologies.

 

7. Leva Anterior Interbody System from Spine Wave.

 

8. AVAmax Vertebral Balloon, AVAflex Vertebral Balloon from Stryker.

 

9. Choice Spine Lumbar Spacer, Choice Spine Interbody Fusion System, Choice Spine Vertebral Body Replacement System from Choice Spine.

10. CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System from L&K Biomed.

11. Preference Elite Pedicle Screw System from Amedica.

12. AccuFit Lateral Plate System from Precision Spine.

13. Dio Medical IVA (ACIF, DLIF, PLIF, TLIF and ALIF) Cage from Dio Medical.

14. Moss 100 Pedicle Screw System from Biedermann Motech.

15. Tritanium PL Cage from Stryker.

 

16. Reform POCT System from Precision Spine.

 

17. Luna 3D Interbody Fusion System from Benvenue Medical.

18. 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) from Pan Medical.

19. Fortezza Spinal Stabilization System from OSSO Surgical.

20. CastleLoc Spinal Fixation System from L&K Biomed.

 

21. Irix-C Cervical Integrated Fusion System from X-Spine Systems.

 

22. T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System from Synthes USA.

 

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