47 spine devices receive FDA 510(k) clearance in Q1

Spinal Tech

The FDA cleared 47 spine devices in the first quarter of 2020.

January

1. Nex-D2 Posterior Fixation System from OrthoSurgical.
2. Genesys Spine 3DP Cervical Interbody System from Genesys Spine.
3. Endoskeleton TL Interbody Fusion Device from Titan Spine.
4. Symphony OCT System from Medos International.
5. Evol ha – D Lateral Interbody Fusion System from Cutting Edge Spine.
6. Anatomic PEEK Cervical Fusion System from Medtronic Sofamor Danek.
7. TrellOss-L MPF from Nexxt Spine.
8. Streamline TL Spinal Fixation System from Pioneer Surgical Technology.
9. CD Horizon Fenestrated Screw Set from Medtronic Sofamor Danek.
10. ProLift Expandable System from Life Spine.
11. CapLOX II / TowerLOX MIS Pedicle Screw System from Captiva.
12. SureMAX Family of Cervical Spacers from Additive Implants.
13. M.U.S.T. Pedicle Screw System from Medacta International.
14. Nexxt Matrixx System from Nexxt Spine.
15. CorticaLINK Spinal Fusion Platform from Spine Smith Holdings.

February

16. Atlas Spine Expandable Cervical Standalone Interbody System from Atlas Spine.
17. Yukon OCT Spinal System from Stryker.
18. Mojave Expandable Interbody System from Stryker.
19. Daytona Small Stature Growth Rod Conversion Set from SeaSpine Orthopedics.
20. Largo PEEK Interbody System from FloSpine.
21. KMTI Teresa SA Anterior Lumbar Interbody Fusion System form Kyocera.
22. Perla TL Posterior Osteosynthesis System from Spineart.
23. Nexxt Matrixx System from Nexxt Spine.
24. OrthoCircle Spine Pedicle Screw System from OrthoCircle Spine.
25. NuVasive X-Core Expandable VBR System from NuVasive.
26. Steerable Plateau Ti from Life Spine.
27. SpineNet SSP System from SpineNet.
28. Daytona Small Stature Spinal System from SeaSpine Orthopedics.

March

29. Megafix Pedicle Screw Spinal System from SeohanCare.
30. Capstone Spinal System, Clydesdale PTC Spinal System, Crescent Spinal System from Medtronic Sofamor Danek.
31. Icotec Cervical Cage from icotec.
32. Mecta-C Stand Alone from Medacta.
33. Response Spine System from OrthoPediatrics.
34. Nano FortiFix System from Nanovis Spine.
35. CarboClear Lumbar Cage System from CarboFix Orthopedics.
36. SeaSpine Skipjack System from SeaSpine Orthopedics.
37. Tritium Sternal Cable Plate System from Pioneer Surgical Technology.
38. SI-Bone iFuse Implant System from SI-Bone.
39. NuVasive Cohere Thoracolumbar Interbody System from NuVasive.
40. NuVasive 3DP Interfixated ALIF System from NuVasive.
41. NorthStar OCT Spinal System from SeaSpine Orthopedics.
42. MectaLIF Anterior Simple from Medacta International.
43. Response BandLoc Spinal Fixation from OrthoPediatrics.
44. SEA-LINK Anterior Cervical Plate System from Indius Medical Technologies.
45. LOSPA IS Spinal Fixation System from Corentec.
46. The Gecko Spinal System from Ortho Development Corporation.
47. Nexxt Matrixx Stand Alone Cervical-Turn Lock System from Nexxt Spine.

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