31 orthopedic devices receive FDA 510(k) clearance in July

Spinal Tech

The FDA cleared 31 orthopedic and spine related devices last month.

 

1. UNiD Patient-matched PLIF cage from Medicrea International.

2. Medtronic Total Hip Arthroplasty System from Medtronic Advanced Energy.

3. Arthrex Eclipse Shoulder Prosthesis System from Arthrex.

4. Velofix TLIF Cage from U&I Corporation.

5. Tritanium X PL Expandable Posterior Lumbar Cage from Stryker Spine.

6. Addivation Medical Cervical Interbody System from Addivation Medical.

7. OrthoPediatrics Cannulated Screw System from Orthopediatrics.

8. 4CIS Chiron Spinal Fixation System from Solco Biomedical.

9. ProLift Expandable System from Life Spine.

10. Fortilink IBF System with Tetrafuse 3D Technology from Pioneer Surgical Technology.

11. Arthrex NanoScope System from Arthrex.

12. Favo S-TLIF from Silony Medical.

13. Rigidlooop Titanium Button, Rigidloop Cortical Fixation System XL Implant from Medos International.

14. Corin Optimized Position System Functional Hip Analysis from Corin USA.

15. Mountaineer OCT Spinal System, Summit SI OCT Spinal Fixation System,
Symphony OCT System, Summit Fixation System from Medos International.

16. OsteoFab Suture Anchors from Oxford Performance Materials.

17. Hammertoe Truss System from 4Web.

18. Article-L 3D Ti Spinal System with TiONIC Technology from Medtronic Sofamor Danek.

19. Salvo Spine System from Spine Wave.

20. ExcelsiusGPS Spine 1.1 Interbody Module from Globus Medical.

21. NuVasive Camber Laminoplasty System from NuVasive.

22. Infinity Fixation System from ConMed Corp.

23. Journey II Unicompartmental Knee System from Smith & Nephew.

24. Empowr Partial Knee from Encore Medical.

25. Harrier-SA Lumbar Interbody System from ChoiceSpine.

26. Revival Modular Hip Stem from Corin USA.

27. Nexxt Matrixx System from Nexxt Spine.

28. CoLink Mini Plating System from In2Bones USA.

29. Mariner MIS Pedicle Screw System; SeaSpine Navigation System from SeaSpine Orthopedics Corp.

30. Ortholoc SPS Shoulder Plating System from Tornier.

31. Europa Pedicle Screw System from MiRus.

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