44 orthopedic devices receive FDA clearance in October

Spinal Tech

The FDA cleared 44 orthopedic-related devices in October 2018.

1. Cellent Spinal Systems from Jiangsu Trauhui Medical Instrument.

2. Humeral Short Stem System from Shoulder Innovations.

3. Titanium TomoFix Medial High Tibia Plate Anatomical from Synthes Products.

4. b-ONE Total Knee System from b-One Ortho Corp.

5. Anthem Fracture System from Globus Medical.

6. WishBone Medical Plate and Screw System from WishBone Medical.

7. Arix Clavicle System from Jeil Medical Corp.

8. Orthros Posterior Stabilization System; Orthros MIS Posterior Stabilization System from Camber Spine.

9. AxSOS 3 Ti from Stryker.

10. World Total Knee System from Signature Orthopaedics.

11. SpineEx Sagittae Lateral Lumbar Interbody Fusion Devices from SpineEx.

12. Cios Spin from Siemens Medical Solutions USA.

13. Cios Alpha from Siemens Medical Systems.

14. BKS Revision Sleeves System from Ortho Development Corp.

15. Ortholoc SPS Shoulder Plating System from Tornier.

16. Spine Wave Navigated Instruments from Spine Wave.

17. Everest Spinal System, Range (Mesa and Denali) Spinal System, Caspian OCT (Mesa Mini and Denali Mini) Spinal System, Yukon OCT Spinal System from K2M.

18. Stable-C Interbody System from Nexus Spine.

19. X-Bolt Hip Fracture Fixation System from X-Bolt Orthopaedics.

20. EIT Cellular Titanium Lumbar Cage LLIF from EIT Emerging Implant Technologies.

21. Life Spine Laminoplasty System from Life Spine.

22. DynaBridge from Fusion Orthopedics.

23. Scarlet AL-T from Spineart.

24. Percuvance Percutaneous Surgical System from Teleflex Medical.

25. NuVasive Cohere Thoracolumbar Interbody System from NuVasive.

26. Outlet Sacroiliac Joint Fusion System from SIJ Surgical.

27. Firefly Midline Navigation Guide from Mighty Oak Medical.

28. Persona Revision Knee System from Zimmer Biomet.

29. Symphony OCT System from Medos International SARL.

30. Integra Titan Reverse Shoulder System from Integra Lifesciences.

31. Piccolo Composite Plate System from CarboFix Orthopedics.

32. Prase MIS Spinal System from GBS Commonwealth.

33. Balance Knee Revision System Trabecular Tibial Cone Augments from Ortho Development Corp.

34. Monet Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate from CTL Medical Corp.

35. DePuy Synthes Femoral Neck System from Synthes USA Products.

36. Olympic Posterior Spinal Fixation System from Astura Medical.

37. PASS LP Spinal System from Medicrea International.

38. ICONN Revolution Knotless Suture Anchor from ICONN Orthopedics.

39. FUSE Pedicle Screw System from Black Box Medical.

40. Duo Lumbar Interbody Fusion Device from Spineology.

41. Powerease System from Medtronic Sofamor Danek.

42. AOS Calcaneal Plating System from Advanced Orthopaedic Solutions.

43. Geminus Volar Distal Radius Plate System from Skeletal Dynamics.

44. Exactech Equinoxe Small Reverse Shoulder Glenospheres from Exactech.


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