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

Spinal Tech

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

1. Metallic Locking Bone Plate and Screw from Canwell Medical.

 

2. NuVasive Sterilization Trays from NuVasive.

 

3. SterilContainer S from Aesculap.

 

4. Total Knee Application from MAKO Surgical.

 

5. Cascade Interbody System from K2M.

 

6. Stryker Suture Tape from Stryker.

 

7. OsteoSelect Plus Demineralized Bone Matrix Putty from Bacterin.

 

8. Arthrex DX SwiveLock Suture Anchor from Arthrex.

 

9. Synfix Evolution Secured Spacer System from Synthes.

 

10. Vitality Spinal Fixation System from Zimmer Spine.

 

11. Materialise TKA Guide System from Materialise.

 

12. O-Arm O2 Imaging System from Medtronic.

 

13. Aesculap T-Space PEEK and XP Spinal System from Aesculap Implant Systems.

 

14. Watson Metallic Bone Plate and Screw Systems from Changzhou Waston.

 

15. Solitaire-C Cervical Spacer System, C-thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System from Biomet Spine.

 

16. Capstone Spinal System, Clydesdale Spinal System from Medtronic Sofamor Danek.

 

17. LnK Lumbar Interbody Fusion Cage System from L&K Biomed.

 

18. MasterGraft Contain from Medtronic Sofamor Danek.

 

19. Everest Spinal System from K2M.

 

20. Medline Foot Plates and Screws from Medline.

 

21. Arthrex BioSync Bone Wedge from Arthrex.

 

22. U2 Hip Stem, Ti Porous Coated Matrix from United Orthopedic.

 

23. Frontier Medical Devices Posterior Cable Screw System from Frontier Medical Devices.

 

24. NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, Expandable XLIF System from NuVasive.

 

25. Conventus PRS System from Conventus Orthopaedics.

 

26. Reform Pedicle Screw System from Precision Spine.

 

27. Continuum and Trilogy Integrated Taper Acetabular Systems from Zimmer.

 

28. Integra Total Ankle Replacement System from Ascension Orthopedics.

 

29. Angel Pedicle Screw Spinal System from Jiangsu Angel Medical Instrument.

 

30. Arthrex Fracture Plates from Arthrex.

 

31. Jazz System from Implanet.

 

32. HA Minuteman G3 MIS Fusion Plate from Spinal Simplicity.

 

33. SteriSpine LC Cage from Safe Orthopaedics.

 

34. SImmetry Sacroiliac Joint Fusion System from Zyga Technology.

 

35. Precision Spine Interspinous Plate System from Precision Spine.

 

36. VariAx 2 One-Third Tubular Plating System from Stryker.

 

37. MultiFIX P Knotless Fixation Device from ArthroCare.

 

38. Salvation External Fixation System from Wright Medical Technology.

 

39. Sniper Spine System from SpineWave.

 

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