22 spine devices receive FDA 510(k) clearance in April

Spinal Tech

The FDA granted 22 spine-related device clearances in April.

 

1. Nile Proximal Fixation Spinal System from K2M.
2. Zavation IBF from Zavation.
3. Ax Stand-Alone ALIF System from Innovasis.
4. Precice Unyte CoCr System from NuVasive Specialized Orthopedics.
5. Mazor X from Mazor Robotics.
6. Leva Anterior Expandable Spacer System from Spine Wave.
7. Endoskeleton TAS Interbody Fusion Device/Hyperlordic Interbody Fusion Device from Titan Spine.
8. Anthem Fracture System from Globus Medical.
9. SurgTech Thoracolumbosacral Posterior Fixation System from SurgTech.
10. Navigated Elevate Inserter, Navigated Disc Prep Instruments from Medtronic Sofamor Danek USA.
11. Capri Corpectomy Cage System from K2M.
12. Threshold Pedicular Fixation System from Spineology.
13. Threshold V2 Pedicular Fixation System from Spineology.
14. Palisade Pedicular Fixation System from Spineology.
15. Fortress Pedicular Fixation System from Spineology.
16. CD Horizon Fenestrated Screw Set from Medtronic Sofamor Danek.
17. Joimax Endovapor 2 from joimax GmbH.
18. Summit Spine Yellowstone Lumbar Interbody Fusion System from Summit Spine.
19. NuVasive BASE Interfixated Titanium System from NuVasive.
20. The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems from Choice Spine.
21. Tomcat Cervical Spinal System from Choice Spine.
22. Zenius Spinal System from Medyssey USA.

 

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