35 orthopedic devices receive FDA 510(k) clearance in May

Spinal Tech

The FDA cleared 35 orthopedic devices in May.

1. DePuy Synthes Sterilization Container from Synthes USA.

2. MobileLink Acetabular Cup System from Waldemar Link.

3. IntraLock Lapidus System from Fusion Orthopedics.

4. AccelFix Spinal Fixation System from L&K BioMed.

5. Zimmer M/L Taper Hip Prosthesis with kinectiv Technology MR Labeling from Zimmer.

6. Half Dome Posterior Lumbar Interbody System from Astura Medical.

7. Synmesh System from DePuy Synthes Spine.

8. Delta Xtend Reverse Shoulder System from DePuy.

9. Fuji Cervical Plate System from Altus Partners.

10. Luna 3D Gen2 Interbody Fusion System from Benvenue Medical.

11. Vanguard Complete Knee System from Zimmer.

12. Revolution Radial Head from Ignite Orthopedics.

13. Mariner Outrigger Revision System from SeaSpine Orthopedics.

14. UNiD Patient Specific 3D Printed TLIF cage from Medicrea International.

15. Colosseum Mesh from Globus Medical.

16. Capstone Control Spinal System from Medtronic Sofamor Danek.

17. MVP Cervical Plate System from GS Medical.

18. Boomerang Anterior Cervical Plate System from ChoiceSpine.

19. InCore Lapidus Sterile Kits from Nextremity Solutions.

20. Arthrex DynaNite PIP Hammertoe Implant from Arthrex.

21. Precision Casting Solutions Total Knee System from Precision Casting Solutions.

22. PASS LP Spinal System from Medicrea.

23. MatrixRIB Fixation System from DePuy Synthes.

24. MedactaLock PEEK Suture Anchor from Medacta International.

25. Ignite Bone Void Filler from Wright Medical Technology.

26. Nexxt Matrixx Stand Alone Cervical System from Nexxt Spine.

27. Cervical Plate from EiserTech.

28. KeYi Spinal Fixation System from Beijing KeYi Medical Device Technology.

29. Cayman LP Plate System from K2M.

30. Aptis Medical Distal Radio Ulnar Joint Implant from Aptis Medical.

31. Cygnus Anterior Cervical Plate System from MiRus.

32. Ortholoc 2 Lapidus with Rotation System from Wright Medical Technology.

33. Juliet Ti LL Lumbar Interbody Device from Spineart.

34. Rampart One Lumbar Interbody Fusion System from Spineology.

35. Masterlock Extension from Medacta.


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