18 spine devices receive FDA 510(k) clearance in October

Spinal Tech

The Food and Drug Administration granted 18 spine-related clearances in October.

1. Valeo Spacer System and Valeo II Interbody Fusion Device System from Amedica.

 

2. NuVasive VuePoint II OCT System from NuVasive.

 

3. Talos Intervertebral Body Fusion Devices, Talos-C Cervical Intervertebral Body Fusion, Talos –C (HA) Cervical Intervertebral Body Fusion Devices from Meditech Spine.

 

4. PASS OCT Spinal System from Medicrea.

 

5. Concorde Bullet Spinal System from Medos.

 

6. Inion Spinal Graft Containment System from Inion Oy.

 

7. Lospa IS Spinal System from Corentec.

 

8. Endoskeleton TCS Interbody Fusion Device from Titan Spine.

 

9. Altus Spine Pedicle Screw System from Altus Partners.

 

10. iFuse Implant System from SI-BONE.

 

11. SteriSpine PS from Safe Orthopaedics.

 

12. S4 Cervical Spinal and Occiput Systems from Aesculap Implant Systems.

 

13. Genesys Spine TiLock2 Spinal System from Genesys Spine.

 

14. Opticage Expandable Interbody Fusion Device from Interventional Spine.

 

15. Vertex Reconstruction System from Medtronic Sofamor Danek.

 

16. Amendia Cervical Plate System from Amendia.

 

17. CD Horizon Spinal System from Medtronic Sofamor Danek.

 

18. EOS System from EOS Imaging.

 

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