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

Spinal Tech

The FDA granted 33 orthopedic and spine devices 510(k) clearance in July.

 

1. Integra Capture Screw System and Integra Ti6 Internal Fixation System from Ascension Orthopedics.

 

2. U2 Femoral Head from United Orthopedic Corp.

 

3. Spider Cervical Plating System from X-Spine Systems.

 

4. Spinal Manometer NRFit, Spinal Manometer LUER from PAJUNK GmbH.

 

5. Arix Ankle Distal Tibial System from Jeil Medical Corp.

 

6. NeoFuse Ti3D PLIF/TLIF/Cervical Interbody from HT Medical.

 

7. dynaMX Intramedullary Implant from Arthrex.

 

8. Anchorman Tibial Ligament Fixation Device from Summit Medical.

 

9. Endoskeleton TO Interbody Fusion Device from Titan Spine.

 

10. EIT Cellular Titanium Cervical Cage, PLIF Cages, TLIF, Cages, Alif Cages from EIT Emerging Implant Technologies.

 

11. In2Bones Fracture and Correction System from In2BonesUSA.

 

12. Coveris Cervical Cage System from Camber Spine Technologies.

 

13. Genius Total Knee System from Signature Orthopaedics.

 

14. HD Lumbar Interbody System from HD LifeSciences.

 

15. True Spinal Fixation System from Innovative Surgical Designs.

 

16. Unity Total Knee System from Corin USA.

 

17. Gemini-C Hybrid Cervical Interbody System from Osseus Fusion Systems.

 

18. Crescent Spinal System from Medtronic Sofamor Danek.

 

19. SeaSpine Cambria System from SeaSpine Orthopedics.

 

20. Biomet Knee Joint Replacement Prostheses from Biomet.

 

21. MP LeFort I Plates from Stryker.

 

22. Haven Laminoplasty System, Canopy Laminoplasty Fixation System from Globus Medical.

 

23. Eagle Plus Anterior Cervical Plate System from Medos International.

 

24. Hammertoe Correction System from Life Spine.

 

25. True Spinal Fixation System from Innovative Surgical Designs.

 

26. Genesys Spine Apache Interbody Fusion System from Genesys.

 

27. Rampart L Lumbar Interbody Fusion Device from Spineology.

 

28. Velofix Interbody Fusion System from U&I Corp.

 

29. OrthAlign Plus System from OrthAlign.

 

30. OpenLoc-L Spinal Fixation System from L&K Biomed.

 

31. TiLock2 Spinal System from Genesys Spine.

 

32. Vitality Spinal Fixation System from Zimmer Biomet Spine.

 

33. Klassic HD Hip System from Total Joint Orthopedic.

 

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