35 orthopedic devices receive FDA 510(k) clearance in August

Spinal Tech

The FDA granted 35 orthopedic- and spine-related device clearances in August.

 

1. Remedy Plus Hip Spacer, Unite Plus Bone Cement from OsteoRemedies.

2. b-ONE Total Hip System from b-One Ortho Corp.

3. Arthrex SwiveLock from Arthrex.

4. Firebird Spinal Fixation System from Orthofix.

5. Geister retractor for neuro- and spine surgery from Geister Medizintechnik.

6. Seculok Suture Anchor from U & I Corp.

7. K2M Expandable Interbody System from K2M.

8. TirboLOX-L Lumbar IBFD from Captiva Spine.

9. Aptus CMC-I Fusion Plate System from Medartis.

10. AOS Small Fragment Plating System Lite from Advanced Orthopaedic Solutions.

11. ASK System from L and K Biomed Corporation Limited.

12. IlluminOss Bone Stabilization System from IlluminOss Medical.

13. Glidesheath Slender Tibial Pedal Kit from Terumo Medical.

14. SpineJack Expansion Kit from Vexim.

15. Genesys Spine AIS-C Cervical Stand-Alone System from Genesys Spine.

16. Aries Lumbar Interbodies from Osseus Fusion Systems.

17. NuVasive Brigade Lateral System from NuVasive.

18. Aptus Proximal Humerus System from Medartis.

19. Atec Cervical Spacer System from Alphatec Spine.

20. Accufuse Cervical System from Absolute Advantage Medical.

21. Tranquil Interbody System from Nexus Spine.

22. Arthrex PushLock Tenodesis Anchor from Arthrex.

23. Evos Wrist Fracture Plating System from Smith & Nephew.

24. Cure Opel-C Plate System from Meditech Spine.

25. Curiteva Midline Anterior Cervical Plate System from Curiteva.

26. Infinity Total Ankle System from Wright Medical Technology.

27. Curiteva Anterior Cervical Plate System from Curiteva.

28. Redi-Spine from Innovative Surgical Designs.

29. Kodiak Spinal Fixation System from Alphatec Spine.

30. ICONN Answer II Suture Anchor from ICONN Orthopedics.

31. NovoStitch Pro Meniscal Repair System from Ceterix Orthopaedics.

32. Duo Lumbar Interbody Fusion Device from Spineology.

33. Gryphon Anchors with Dynacord Suture from Medos International.

34. Zenius, Iliad and Kora Spinal Fixation Systems from Medyssey USA.

35. CD Horizon Spinal System from Medtronic Sofamor Danek.

 

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