43 orthopedic devices receive FDA 510(k) clearance in August

Spinal Tech

The FDA cleared 43 orthopedic and spine related devices in August.


1. Elaris Pedicle Screw System from SpineWelding.

2. Conformity Stem from United Orthopedic Corporation.

3. Dr J Spinal and Epidural Needles from Dr. Japan Co.

4. Spine & Trauma Navigation from Brainlab.

5. Libertas – Taper Uncemented Femoral Stem from Maxx Orthopedics.

6. Evol SI Joint Fusion System from Cutting Edge Spine.

7. VS Orthopedics System from 3D Systems.

8. BOSS Toe Fixation System from Arthrosurface.

9. CoLink Plating System from In2Bones USA.

10. Triathlon Total Knee System – Additional Components from Stryker Orthopaedics.

11. iTotal Identity Cruciate Retaining Knee Replacement System from ConforMIS.

12. Signature Ceramic Femoral Head from Signature Orthopaedics.

13. TriMAX Implant System from CrossRoads Extremity System.

14. Cervical Spinal Truss System-Stand Alone from 4Web.

15. Elevation Spine Saber-C System from Elevation Spine.

16. ConforMIS BeneFIT Hip System from ConforMIS.

17. Triathlon Tritanium Central Femoral Cone Augmentation from Howmedica Osteonics.

18. OrthoPediatrics PediFoot Deformity Corrections System from OrthoPediatrics.

19. SurgTech GENOLL Total Knee System from SurgTech.

20. ATEC Lateral Interbody System from Alphatec Spine.

21. Zavation eZspand Interbody System from Zavation Medical Products.

22. CrossRoads Screw System from CrossRoads Extremity Systems.

23. Infinity Total Ankle System from Wright Medical Technology.

24. Biolox Contoura Ceramic Femoral Head from Total Joint Orthopedics.

25. VariAx 2 System from Stryker.

26. Interphalangeal Joint Fusion Device Range from Neosteo.

27. Facilis Spinal System from Baui Biotech.

28. NuVasive Reline Cervical System from NuVasive.

29. Exactech Equinoxe Humeral Augmented Trays from Exactech.

30. Endoskeleton TCS Interbody Fusion Device from Titan Spine.

31. ARx Spinal System from Life Spine.

32. ChoiceSpine Octane A/T/P Spinal Implant System from ChoiceSpine.

33. Aptus Foot System from Medartis.

34. Cyclops Anterior Cervical Plate System from DeGen Medical.

35. Curiteva Pedicle Screw System from Curiteva.

36. Creo Stabilization System from Globus Medical.

37. iNSitu Total Hip System from Thecken Companies.

38. Remedy Acetabular Cup from OsteoRemedies.

39. Endoskeleton TA Interbody Fusion Device from Titan Spine.

40. NCB Polyaxial Locking Plate System from Zimmer.

41. Rampart One Lumbar Interbody Fusion System from Spineology.

42. Endoskeleton TAS Plate form Titan Spine.

43. Binary Anterior Cervical Plate System from Genesys Spine.

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