42 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in August

Spinal Tech

The Food and Drug Administration issued 42 orthopedic- and spine-related 510(k) Clearances in August, according to an FDA report. 1. United U2 XPE Total Knee System from United Orthopedic Corporation.

2. Mesa Spinal System (Keystone Rods) from K2M.

3. Arthrex Distal Extremity Plate System from Arthrex.

4. Del Mar Monoaxial Pedicle Screw System from Phygen.

5. Vu C Pod Intervertebral Body Device from Theken Spine.

6. Care Back pain Relieve Stimulator from ShenZhen Dongdixin Technology.

7. KneeHab XP from Bio-Medical Research.

8. Aesculap SIBD XP Spinal System from Aesculap Implant Systems, a B. Braun Company.

9. Stryker Spine Power Adapter (Accessory Instrument) from Stryker.

10. Corin Optimom Modular Head from Corin USA.

11. Perimeter C. Spinal System from Medtronic Sofamor Danek.

12. Orthopediatrics Blade Plate System from Orthopediatrics.

13. Rog Suture Anchor and Rog Knotless Suture Anchor from Rog Sports Medicine.

14. Synthes 3.5MM LCP Clavicle Plate System from Synthes USA.

15. Y-Knot All-Suture Anchor from Conmed Linvatec.

16. T2 Femoral Nail from Stryker.

17. Crescent Spinal System Titanium from Medtronic Sofamor Danek.

18. SpeedLock Knotless Fixation Device from ArthroCare.

19. Synthes Ria System (Expanded Indications) from Synthes USA.

20. Universal Clamp Spinal Fixation System from Zimmer Spine.

21. Romeo Posterior Osteosynthesis System from Spineart.

22. Infill Graft Delivery System from Pinnacle Spine Group.

23. TruMatch Personalized Solutions from DePuy Orthopaedics.

24. Pyrenees Cervical Plate System from K2M.

25. SMR Reverse Shoulder System from Lima Corporate.

26. Biomet Sports Medicine Juggerknot Mini Soft Anchor from Biomet.

27. Trimed Radiocarpal Fusion System from Trimed.

28. Staxx XDL System from Spine Wave.

29. ProFemur E. Cementless Hip System from Wright Medical Technology.

30. ProFemur Z Titanium Plasma Sprayed Hip Stem from Wright Medical Technology.

31. Polaris Spinal System from Biomet Spine.

32. LCCS Insulated Spinal Needle from LCCS Products.

33. Evolve Triad Plating System and Evolve Triad Bone Screws from Wright Medical Technologies.

34. Nugait Subtalar Implant system from Ascension Orthopedic.

35. Arthrex Scapholunate Anchor from Arthrex.

36. Talon DistalFix Proximal Femoral Nail from Orthopedic Designs North America.

37. Stremline Spinal System from Pioneer Surgical Technology.

38. Perimeter Interbody Fusion Device from Medtronic Sofamor Danek.

39. Chesapeake (Cervical Components) from K2M.

40. Pioneer Aspect Anterior Cervical Plate from Pioneer Surgical.

41. Daytona Anterior Cervical Cage from SpineNet.

42. Novae Sunfit Dual Mobility Acetabular Cup from Serf.

43. DePuy St.Tune Knee System from DePuy Orthopaedics.

Related Articles on FDA Approvals:

46 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in July

29 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in June

35 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in May



Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Webinars

Featured Podcast

Featured Whitepapers