34 orthopedic devices receive FDA 510(k) clearance in March

Spinal Tech

The FDA granted 34 orthopedic- and spine-related device clearances in March.

 

1. Spectrum Spine Expandable Cages from Spectrum Spine.

2. Europa Pedicle Screw System from MiRus.

3. Mutars Proximal Femur Replacement System from implantcast.

4. MLP Special Locking Bone Plate System from Maxxion Medical.

5. Alteon Acetabular Cup System from Exactech.

6. Freedom Spinal Cord Stimulatory System from Stimwave Technologies.

7. ISS-Jazz Screw System and Jazz Cap from Implanet.

8. Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads from Arthrex.

9. Rosa One Spine application from Medtech.

10. MiRus Lumbar Interbody Fusion System from MiRus.

11. Wright Jones Fracture System from Wright Medical Technology.

12. Kuros TLIF Cage from Kuros Biosciences.

13. Mimics Medical from Materialise.

14. The Progressive Orthopaedic Company Total Knee System II from The Progressive Orthopaedic Company.

15. ChoiceSpine Stealth Cervical Spacer System from ChoiceSpine.

16. MectaLIF Anterior Stand Alone Extension from Medacta.

17. Modular Spinal Fixation System from Life Spine.

18. DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio from
Synthes USA.

19. Parcus Twist AP Suture Anchors from Parcus Medical.

20. Klassic Knee System from Total Joint Orthopaedics.

21. Arthrex TensionLoc System from Arthrex.

22. IdentiTi Porous Ti Interbody System from Alphatec Spine.

23. Duo Lumbar Interbody Fusion Device from Spineology.

24. SpineEx Sagittae Lateral Lumbar Interbody Fusion Devices from SpineEx.

25. Corus Spinal System from Providence Medical Technology.

26. Evos Small Fragment Upper Extremity Plates Line Additions from Smith & Nephew.

27. Provident II Hip Stem from StlKast.

28. Prostim Injectible Inductive Graft from Wright Medical Technology.

29. Scarlet AC-T Secured Anterior Cervical Cage from Spineart.

30. Zavation Spinal System from Zavation Medical Products.

31. NuVasive VersaTie System from NuVasive.

32. CastleLoc-P Anterior Cervical Plate System from L&K Biomed.

33. OsteoCentric Bone Plate and Screw System from OsteoCentric Trauma.

34. Responsive Arthroscopy Wedge Push-In Suture Anchors from Responsive Arthroscopy.

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