16 spine devices receive FDA 510(k) clearance in March

Spinal Tech

The Food and Drug Administration granted 16 spine-related device clearances in March.

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

 

2. NuVasive CoRoent System from NuVasive.

 

3. Biomet Spine Fusion System from Biomet Spine.

 

4. PASS LP Spinal System from Medicrea.

 

5. Xenco Medical Lumbar Interbody System from Xenco Medical.

 

6. LnK Anterior Cervical Plate System from L&K Biomed.

 

7. Affix IIS Spinous Process Plate System from NuVasive.

 

8. AccuLIF TL and PL Cage from Stryker.

 

9. inVizia Anterior Cervical Plate System from Zimmer Spine.

 

10. NuVasive NVM5 System from NuVasive.

 

11. Leva Spacer System from Spine Wave.

 

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

 

13. Tarsa-Link Wedge Fixation System from Life Spine.

 

14. Nautilus Spinal System from Life Spine.

 

15. LITe Plate System from Stryker.

 

16. Integra Laminoplasty System from SeaSpine.

 

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