52 spine, orthopedic devices receive FDA 510(k) clearance in January

Spinal Tech

The Food and Drug Administration cleared 52 orthopedic- and spine-devices in January.

1. Spinous Process Fusion Plate from Spinal Simplicity.

 

2. MaxiMIS Spinal Fixation System from Valorem Surgical.

 

3. Excera Fitrite Total Hip Arthroplasty System from Excera Orthopedics.

 

4. Patient Specific Distal Femoral from Stanmore Implants Worldwide.

 

5. Firebird Spinal Fixation System from Orthofix.

 

6. Impix ALIF from Medicrea International.

 

7. New Era Orthopaedics Polyscrew Pedicle Screw System from New Era Orthopaedics.

 

8. Pass LP Spinal System from Medicrea International.

 

9. High Tibial Osteotomy System from newClip Technics.

 

10. SImmetry Sacroiliac Joint Fusion System from Zyga Technology.

 

12. Divergence Anterior Cervical Fusion System from Medtronic.

 

13. CrossTie Intraosseous Fixation System from OrthoDiscovery.

 

14. Leva Spacer System from Spine Wave.

 

15. InFix Cannulated Screw System from InFix Medical.

 

16. Construx Mini PEEK; Spacer System, TI Spacer System, Cervical and Standalone System from Orthofix.

 

17. OMNI Interface Acetabular System from OMNILife Science.

 

18. Aviator Anterior Cervical Plate System from Stryker.

 

19. Everest Spinal System from K2M.

 

20. PRECISE Trauma Nail System from Ellipse Technologies.

 

21. CB PROT II Posterior Spinal System from Chin Bone Technique.

 

22. Oasys System from Stryker.

 

23. EOS System from EOS Imaging.

 

24. Synapse Occipital-Cervical-Thoracic System from Synthes.

 

25. Lumenis M22 System from Lumenis.

 

26. Revolution Spinal Fixation System from Intelligent Implant Systems.

 

27. Endoskeleton TCS System from Titan Spine.

 

28. Biosure Regenesorb interference screw from Smith & Nephew.

 

29. Ideal pedicle screw spinal system from Jiangsu Ideal Medical Science.

 

30. Proficient Facet Screw Spine System from Spine Wave.

 

32. SnapShot Fixation System from Biomet.

 

33. CrossRoads Screw System from OrthoDiscovery.

 

34. Activ Ankle Locking Plating System.

 

35. NuVasive ALIF Buttress Plate System from NuVasive.

 

36. Stryker SonicPin System, Stryker SonicAnchor System from Stryker Trauma.

 

37. Arthrex Fracture System from Arthrex.

 

38. Arsenal Spinal Fixation System from Alphatec Spine.

 

39. Cannulated PediGuard Needle from SpineGuard.

 

40. AVS AL and Align PEEK Spacers from Stryker.

 

41. Sidekick EZ Frame External Fixation System from Wright Medical Technology.

 

42. Range/Denali/Mesa Spinal System from K2M.

 

43. ADVANCE Porous Coated Spiked Tibial Base from MicroPort Orthopedics.

 

44. Quattro Bolt Tenodesis Screw from Cayenne Medical.

 

45. Triathlon Tritanium Cone Augments from Stryker Orthopaedics.

 

46. Cannulated Screw System from Wright Medical Technology.

 

47. Verta Corpectomy Cage from Camber Spine.

 

48. MasterSL femoral stem from Lima Corporate.

 

49. Prelude PF Patellae from Biomet.

 

50. Arthrex Low profile Screws from Arthrex.

 

51. Headless Compression Screw System from Skeletal Dynamics.

 

52. CREO Stabilization System from Globus Medical.

 

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