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44 Spine, Orthopedic Devices Receive FDA 510(k) Clearance in March

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The Food and Drug Administration cleared 44 spine- and orthopedic-related medical devices in March.

 

1. AFT Greater Tubersity Fracture Plate from Shoulder Options.

2. Locking Compression Bone Plates and Screw System from Changzhou Dean Medical Instrument.

3. VelofixTM Interbody Fusion System U&I Corp.

4. Apollo Suture Anchor System and Titan Screws from Amendia.

5. Blackbird Spinal System from Choice Spine.

6. Pro-Toe Hammertoe Fixation System from Wright Medical Technology.

7. Interbridge Interspinous Posterior Fixation System from LDR Spine.

8. Van Hip Fracture System form Epix Orthopaedic.

9. DePuy Pinnacle AltrX Acetabular Liners from DePuy Orthopaedics.

10. Acumed Suture Anchor System from Acumed.

11. CMC Mini Tightrope from Arthrex.

12. Revere Stabilization System from Globus Medical.

13. Ovation Tribute Hip Stem; Ovation Narrow Hip Stem from Ortho Development.

14. Polaris Spinal System from Biomet Spine.

15. Capstone PTC Spinal System, Clydesdale PTC Spinal System from Medtronic Sofamor Danek USA.

16. UltraCongruent Insert from United Orthopedic Corporation.

17. Arsenal Spinal Fixation System from Alphatec Spine.

18. Omni Arc Monoblock Hip Stem from OmniLife Science.

19. CD Horizon Spinal System from Medtronic Sofamor Danek.

20. Klassic HD Hip System, Offset Femoral Stem, Non-Porous/Porous from Total Joint Orthopedics.

21. Sterispine LC Cage from Safe Orthopaedics.

22. Streamline OCT Occipito-Cervico-Thoracic System from Pioneer Surgical Technology.

23. Camber Spine Diagon Oblique Cage from Camber Spine.

24. Camber Spine Coveris Cervical Cage from Camber Spine.

25. Range, Spinal System, Everest Spinal System from K2M.

26. Integra Freedom Wrist Arthroplasty System from Integra LifeSciences.

27. Prodense Bone Graft Substitute from Wright Medical Technology.

28. RSP Modular Glenoid Baseplate, Glenoid Taper Adapter, Retaining Screw from Encore Medical.

29. Variax Distal Radius Plate System from Stryker Leibinger.

30. Silex Sacroiliac Joint Fusion System from X-Spine Systems.

31. Nautilus Spinal System from Life Spine.

32. Vega Knee System from Aesculap Implant Systems.

33. Biomet Access System from Biomet Spine.

34. Flower Rear Foot Plating Set, Flower Calcaneus Plating Set, Flower Rearfoot Plating Set from Flower Orthopedics.

35. Anterior Lumbar Interbody Fusion System from Renovis Surgical Technologies.

36. CrossFuse II Coronal Taper, CrossFuse II Hyperlordotic from Pioneer Surgical Technology.

37. I-Hip Total Hip System from Iconacy Orthopedic Implants.

38. OrthoScan FDA Mini C-Arm from OrthoScan.

39. iTotal Cruciate Retaining Knee Replacement System from ConforMIS.

40. Oxford Fixed Lateral Bearing Partial Knee Replacement from Biomet.

41. PEEK Fusion Implant from MTP Solutions.

42. Extremity Medical Hammertoe Device from Extremity Medical.

43. InFill 41-TLIF Convex Oblique Device from Pinnacle Spine.

44. Elite IBF from Innova Spinal Technologies.

 

More Articles on FDA Clearances:
31 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in February
35 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in January
44 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in Deceber


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