39 orthopedic, spine devices receive FDA 510(k) clearance in October

Spinal Tech

The Food and Drug Administration granted 39 orthopedic- and spine-related clearances in October.

1. Valeo Spacer System and Valeo II Interbody Fusion Device System from Amedica.

 

2. Healix BR Anchor from DePuy Mitek.

 

3. Genesis II XLPE Resurfacing Patellar Components from Smith & Nephew.

 

4. NuVasive VuePoint II OCT System from NuVasive.

 

5. Arrow Humeral stems size 6 and 16 from Hospitalieres Industrial.

 

6. Acetabular cup orientation system from Materialise.

 

7. Talos Intervertebral Body Fusion Devices, Talos-C Cervical Intervertebral Body Fusion, Talos-C (HA) Cervical Intervertebral Body Fusion Devices from Meditech Spine.

 

8. H-Max S Femoral Hip System form Limacorporate.

 

9. PASS OCT Spinal System from Medicrea.

 

10. Physica CR Knee System from Limacorporate.

 

11. MIS Spine Frame Instrument Case from Thompson Surgical Instruments.

 

12. Concorde Bullet Spinal System from Medos.

 

13. Inion Spinal Graft Containment System from Inion Oy.

 

14. Lospa IS Spinal System from Corentec.

 

15. Arthrex Glenoid Intelligent Reusable Instrument System from Custom Orthopaedic Solutions.

 

16. MasterLoc Stem from Medacta.

 

17. Endoskeleton TCS Interbody Fusion Device from Titan Spine.

 

18. Arcos One-piece Femoral Revision System from Biomet.

 

19. TiTHON Staple with OsseoTi Technology from Biomet.

 

20. Altus Spine Pedicle Screw System from Altus Partners.

 

21. iFuse Implant System from SI-BONE.

 

22. SteriSpine PS from Safe Orthopaedics.

 

23. Acumed Ankle Small Fragment Base Set Update from Acumed.

 

24. Frontier Medical Devices In-line Orthopedic Cable Cerclage System from Frontier Medical Devices.

 

25. S4 Cervical Spinal and Occiput Systems from Aesculap Implant Systems.

 

26. Genesys Spine TiLock2 Spinal System from Genesys Spine.

 

27. Opticage Expandable Interbody Fusion Device from Interventional Spine.

 

28. Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts from Ortho Development.

 

29. Journey II Uni Tibial Base and Insert from Smith & Nephew.

 

30. Vertex Reconstruction System from Medtronic Sofamor Danek.

 

31. Amendia Cervical Plate System from Amendia.

 

32. CD Horizon Spinal System from Medtronic Sofamor Danek.

 

33. Integra DigiFuse Cannulated Intramedullary Fusion System from Ascension Orthopedics.

 

34. Navio from Blue Belt Technologies.

 

35. OSS/Arcos IM Total Femur Rod from Biomet.

 

36. iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System from ConforMIS.

 

37. HammerFix Device from Extremity Medical.

 

38. Journey II XR Knee System from Smith & Nephew.

 

39. EOS System from EOS Imaging.

 

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