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

Spinal Tech

The FDA cleared 19 spine devices in March 2020.

 

1. Megafix Pedicle Screw Spinal System from SeohanCare.
2. Capstone Spinal System, Clydesdale PTC Spinal System, Crescent Spinal System from Medtronic Sofamor Danek.
3. Icotec Cervical Cage from icotec.
4. Mecta-C Stand Alone from Medacta.
5. Response Spine System from OrthoPediatrics.
6. Nano FortiFix System from Nanovis Spine.
7. CarboClear Lumbar Cage System from CarboFix Orthopedics.
8. SeaSpine Skipjack System from SeaSpine Orthopedics.
9. Tritium Sternal Cable Plate System from Pioneer Surgical Technology.
10. SI-Bone iFuse Implant System from SI-Bone.
11. NuVasive Cohere Thoracolumbar Interbody System from NuVasive.
12. NuVasive 3DP Interfixated ALIF System from NuVasive.
13. NorthStar OCT Spinal System from SeaSpine Orthopedics.
14. MectaLIF Anterior Simple from Medacta International.
15. Response BandLoc Spinal Fixation from OrthoPediatrics.
16. SEA-LINK Anterior Cervical Plate System from Indius Medical Technologies.
17. LOSPA IS Spinal Fixation System from Corentec.
18. The Gecko Spinal System from Ortho Development Corporation.
19. Nexxt Matrixx Stand Alone Cervical-Turn Lock System from Nexxt Spine.

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