20 spine devices receive FDA 510(k) clearance in September

Spinal Tech

The Food and Drug Administration cleared 20 spine-related devices in September.

1. Clydesdale Spinal System from Medtronic.

 

2. Longbow Spacer System from Life Spine.

 

3. Genesys Spine Anterior Buttress Plate System from Genesys Spine.

 

4. General Spinal System from Changzhou Dean Medical Instrument.

 

5. Renaissance X System from Mazor Robotics.

 

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

 

7. Biomet Graft Delivery Syringes from Biomet Spine.

 

8. Xenco Medical Cervical Interbody System from Xenco Medical.

 

9. Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation from Spineart.

 

10. Arena-C from SpineFrontier.

 

11. Mobis II ST Spinal Implant from Signus Medizintechnik GMBH.

 

12. Optio-C Anterior Cervical System from Zimmer Spine.

 

13. Polaris Spinal System – HA Coated from Biomet Spine.

 

14. Mastergraft Matrix EXT; Mastergraft Putty, Mastergraft Strip from Medtronic Sofamor Danek.

 

15. Romeo Posterior Osteosynthesis System from Prebent Cross-Connectors; Prebent Rods from Spineart.

 

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

 

17. Synapse System, Synthes OC Fusion System from Synthes USA.

 

18. Pro-Link Wedge System from Life Spine.

 

19. 4Web Spinal Implant Products from 4Web.

 

20. Via Spinous Process Fixation System from Spineology.

 

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