36 orthopedic devices receive FDA 510(k) clearance in January

Spinal Tech

The FDA cleared 36 orthopedic related devices in January.

1. Nex-D2 Posterior Fixation System from OrthoSurgical.
2. Conformity stem, cemented from United Orthopedic Corporation.
3. Quantum Total Ankle Prosthesis from In2Bones.
4. Genesys Spine 3DP Cervical Interbody System from Genesys Spine.
5. Endoskeleton TL Interbody Fusion Device from Titan Spine.
6. Symphony OCT System from Medos International.
7. Black Diamond Navigation Instruments from Osseus Fusion Systems.
8. Evol ha – D Lateral Interbody Fusion System from Cutting Edge Spine.
9. Anatomic PEEK Cervical Fusion System from Medtronic Sofamor Danek.
10. TrellOss-L MPF from Nexxt Spine.
11. TriMed Aset Foot Plating System from TriMed.
12. Avenger Radial Head System from In2Bones USA.
13. Streamline TL Spinal Fixation System from Pioneer Surgical Technology.
14. Quadra-P from Medacta International.
15. ALLthread Titanium Suture Anchor from Biomet.
16. Tyber Medical Trauma Screws from Tyber Medical.
17. APTUS Clavicle System from Medartis AG.
18. OsteoRemedies Hip Spacer System from OsteoRemedies.
19. CD Horizon Fenestrated Screw Set from Medtronic Sofamor Danek.
20. Attune All-Polyethylene Tibia from DePuy Ireland.
21. TunneLoc Tibial Fixation Device from Biomet.
22. Anatomical Shoulder System from Zimmer.
23. Tyber Medical Anatomical Plating System from Tyber Medical.
24. Persona Personalized Knee System from Zimmer.
25. ProLift Expandable System from Life Spine.
26. CapLOX II / TowerLOX MIS Pedicle Screw System from Captiva.
27. Physica LMC Knee System from Limacorporate.
28. Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor from Parcus Medical.
29. SureMAX Family of Cervical Spacers from Additive Implants.
30. M.U.S.T. Pedicle Screw System from Medacta International.
31. Nexxt Matrixx System from Nexxt Spine.
32. Univers Revers Modular Glenoid System (augmented baseplates) from Arthrex.
33. AMIStem-C from Medacta International.
34. CorticaLINK Spinal Fusion Platform from Spine Smith Holdings.
35. Arthrex SwiveLock Suture Anchor from Arthrex.
36. CoLink Plating System from In2Bones.

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