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

Spinal Tech

The Food and Drug Administration granted 21 spine-related devices in February.

 

1. Alliance Spine RAAS Cranial Plating System from Alliance Partners.

 

2. Nautilus Spinal System and Solstice OCT System from Life Spine.

 

3. Life Spine Sacroiliac Joint Fixation System from Life Spine.

 

4. NuVasive X-Core Expandable VBR System from NuVasive.

 

5. Talos-C (HA) from Meditech Spine.

 

6. Magnify and Magnify-S Spacers from Globus Medical.

 

7. Spinal System from Eisertech.

 

8. StaXx XD System from Spine Wave.

 

9. Renovis S111 Lumbar Interbody Cage System from Renovis Surgical Technologies.

 

10. MIS Z-Pedicle Screw System from Z-Medical.

 

11. Scarlet AC-T Secured Anterior Cervical Cage from Spineart.

 

12. Ancora LLC Interbody Fusion Device from Frontier Medical Devices.

 

13. Palladian Lumbar Pedicle Screw System from Neurostructures.

 

14. Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Replacement from Zimmer Spine.

 

15. CD Horizon Spinal System, Medtronic Navigated Reusable Instruments from Medtronic Sofamor Danek.

 

16. PedFuse Pedicle Screw System from SpineFrontier.

 

17. Anax 5.5 Spinal System from U&I Corporation.

 

18. VERTEX Reconstruction System from Medtronic Sofamor Danek.

 

19. PASS LP Spinal System from Medicrea International.

 

20. SteriSpine PS Pedicle Screw from Safe Orthopaedics.

 

21. CD Horizon Growth Rod Conversion Set from Medtronic Sofamor Danek.

 

 

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