15 spine devices receive FDA 510(k) clearance in June

Laura Dyrda -   Print  |

The FDA cleared 15 spine-related devices in June.


1. AXTi Titanium Stand-Alone ALIF System from Innovasis.

2. Galileo Spine alignment Monitoring System from MiRus.

3. Oyster ACIF Cage from Silony Medical.

4. Spineart Navigation Instrument System from Spineart.

5. Lateral Plate System from CoreLink.

6. LineSider Spinal System from Integrity Implants.

7. Vader one Pedicle System MIS and LightMore Pedicle System 6.0 from icotec ag.

8. Rigel PEEK Anterior Cervical Interbody Fusion System from MiRus.

9. DePuy Synthes Plates and Screws Portfolio from DePuy Synthes.

10. The Jasper Spinal Fixation System II from GBS Communications.

11. Republic Spine Restore Cervical Interbody Fusion
System from Republic Spine.

12. MedactaScrew PEEK Interference Screw from Medacta.

13. Solanas Posterior OCT Fixation System from Alphatec Spine.

14. Idys ALIF TiVac from Clariance.

15. Spine & Trauma Navigation from Brainlab.

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