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

Written by Laura Dyrda | June 10, 2019 | Print  |

The FDA cleared 18 spine-related devices in May.

 1. AccelFix Spinal Fixation System from L&K BioMed.

2. Half Dome Posterior Lumbar Interbody System from Astura Medical.

3. Synmesh System from DePuy Synthes Spine.

4. Fuji Cervical Plate System from Altus Partners.

5. Luna 3D Gen2 Interbody Fusion System from Benvenue Medical.

6. UNiD Patient Specific 3D Printed TLIF cage from Medicrea International.

7. Colosseum Mesh from Globus Medical.

8. Capstone Control Spinal System from Medtronic Sofamor Danek.

9. MVP Cervical Plate System from GS Medical.

10. Boomerang Anterior Cervical Plate System from ChoiceSpine.

11. PASS LP Spinal System from Medicrea.

12. Nexxt Matrixx Stand Alone Cervical System from Nexxt Spine.

13. Cervical Plate from EiserTech.

14. KeYi Spinal Fixation System from Beijing KeYi Medical Device Technology.

15. Cayman LP Plate System from K2M.

16. Cygnus Anterior Cervical Plate System from MiRus.

17. Juliet Ti LL Lumbar Interbody Device from Spineart.

18. Rampart One Lumbar Interbody Fusion System from Spineology.

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