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

Spinal Tech

The FDA cleared 19 spine-related medical devices in October.

 

1. Shanghai Sanyou Carmen Cervical Fusion System from Shanghai Sanyou Medical.

 

2. Bridalveil Occipital Cervical Thoracic System from Astura Medical.

 

3. Acapella Cervical Spacer System from ChoiceSpine.

 

4. Mikron Spinal Fixation System from Mikron Makina Sanayi Ticaret.

 

5. ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System from Medtronic Sofamor Danek.

 

6. Cortina Lumbar Cage System from NeuroStructures.

 

7. Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set from Medtronic.

8. Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap from Stryker.

9. NuVasive Modulus XLIF Interbody System from NuVasive.

 

10. iFuse Implant System – iFuse Navigation from SI-BONE.

 

11. Ortus Expandable Lumbar Interbody Fusion System from Atlas Spine.

12. NuVasive Modulus TLIF Interbody System from NuVasive.

13. Fortilink Interbody Fusion System with TETRAfuse 3D Technology from RTI Surgical.

 

14. Silco Fixation System from Globus Medical.

15. AnyPlus Spinal Fixation System from GS Medical.

16. Liberty Anterior Cervical Plate from Valorus Spine.

 

17. CosmoLock Pedicle Screw System from Kalitec Direct.

 

18. SeaSpine Ventura NanoMetalene System from SeaSpine Orthopedics.

 

19. Viper Prime Screws, Viper Prime Screws with Fenestrations, Expedium Verse Screws with Fenestrations from Medos International.

 

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