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

Spinal Tech

The Food and Drug Administration granted 21 spine-related clearances in March.

1. SurgTech Interbody System from SurgTech.

 

2. S-Wire from Spinal Resources.

 

3. iFuse Implant System from SI-BONE.

 

4. TRYPTIK2C-plate Anterior Cervical Plate System from Spineart.

 

5. PEEK Customized Cranial Implant from Stryker.

 

6. Renovis Tesera SC Stand-alone Anterior Cervical Fusion System from Renovis Surgical.

 

7. Erisma-LP Spinal Fixation System from Clariance.

 

8. JAZZ LOCK from Implanet.

 

9. ProLift Expandable System from Life Spine.

 

10. Perimeter C Spinal System from Medtornic Sofamor Danek USA.

 

11. Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System from LDR Spine USA.

 

12. NuVasive TLX Interbody System from NuVasive.

 

13. NuVasive Lumbar Interbody Implants from NuVasive.

 

14. Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System from Captiva Spine.

 

15. Xspan Laminoplasty Fixation System from X-Spine.

 

16. Nile Alternative Fixation Spinal System from K2M.

 

17. Precice Trauma Nail System from Ellipse Technologies.

 

18. Perimeter Interbody Fusion Device from Medtronic Sofamor Danek.

 

19. Response 5.5 Spine System from Orthopediatrics.

 

20. Anatomic PEEK PTC Cervical Fusion System from Medtronic Sofamor Danek.

 

21. Cascadia Interbody System from K2M.

 

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