15 spine devices receive FDA 510(k) clearance in March 2018

Written by Laura Dyrda | April 19, 2018 | Print  |

The FDA cleared 15 spine-related devices in March.


1. Fortress Radiopaque Bone Cement, Creo Fenestrated Screw System, Revlok Fenestrated Screw System from Globus Medical.

2. Arco-SA Lumbar Cage System from NeuroStructures.

3. Sentio MMG Pedicle Access Needless from Medos International.

4. Mega Plus Spine System from BK Meditech.

5. CD Horizon Spinal System from Medtronic Sofamor Danek.

6. Valeo C+CSC with Lumen Interbody Fusion Device from Amedica.

7. SI Screw System from Zavation Medical Products.

8. Genesys Spine AIS-C Cervical Anchored Interbody System from Genesys Spine.

9. X-spine Cortical Bone Screw System from X-spine Systems.

10. SP-Fix Spinous Process Fixation Plate, Relieve Laminoplasty Fixation System from Globus Medical.

11. NuVasive VuewPoint II OCT System from NuVasive.

12. Polaris Spinal Growth System from Zimmer Biomet Spine.

13. Cortina Lumbar Cage System from NeuroStructures.

14. CapLOX II / TowerLOX MIS Pedicle Screw System from Captiva Spine.

15. Zavation Buttress Plate System from Zavation Medical.


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