FDA Clears 35 Orthopedic and Spine Devices in April

Spinal Tech

The FDA issued 35 orthopedic- and spine-related 510(k) clearances in April, according to a report by the FDA.

1. Smith & Nephew Twinfix Ultra HA Surture Anchor from Smith & Nephew

2. Aegis & Aegis II Spinal System from Corentec

3. Stryker Sonicpin System from Howmedica Osteonics

4. Alexis Orthopaedic Wound Retractor from Applied Medical Resources

5. Minihip Stem from Corin U.S.A.

6. Smith & Nephew Footprint RCX PK Suture Anchor from Smith & Nephew

7. CAS Fixation Pin 3.2x180, 3.2x80, 3.2x150, from Orthosoft

8. Lanx Anterior Plating System from Lanx

9. Apex Arc Hip Stem from Omni Life Science

10. Alpha Orthopaedics AT3 System from Alpha Orthopaedics

11. Synthes Tomofix High Tibia Plate, small, from Synthes

12. DeRoyal Non-Locking Bone Fixation System from DeRoyal Industries

13. NCB Periprosthetic Femur Polyaxial Locking Plate from Zimmer

14. Modification to Trio+Spinal Fixation System from Stryker Spine

15. Zuma-C from Seaspine

16. Verilast Wear Claims for Legion Primary Knee System from Smith & Nephew

17. Synthes Air Pen Drive (APD) System from Synthes

18. Cormet Cementless Resurfacing Femoral Head from Corin USA

19. SLR-Plus Standard and Lateral Femoral Stems from Smith & Nephew

20. Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) from Lanx

21. Peanut Growth Control Plating System from EBI

22. Distalock Femoral Intramedullary Nail System from DGIMED Ortho

23. Smith & Nephew Hip Systems With HA from Smith & Nephew

24. Nanoss Bone Void Filler from Pioneer Surgical Technology

25. Tornier Surgical Mesh from Tornier

26. Diamondback Spinal System from Eminent Spine

27. Sureshot Tan Nails and Accessories from Smith & Nephew

28. Enduramesh Model 762.XXX from Lucero Medical

29. Crescent Spinal System from Medtronic Sofamor Danek

30. Zimmer Trabecular Metal Modular Acetabular System from Zimmer

31. Extremity Medical Screw System from Extremity Medical

32. TSRH Spinal System from Medtronic Sofamor Danek

33. Ringloc + Hybrid Acetabular System from Biomet

34. Axsos Locked Plating System Line Extension of 5mm Locking Inserts from Howmedica Osteonics

35. Gryphon T BR DS, T BR, P BR DS and P BR A Anchor with Orthocord from Depuy Mitek, a Johnson & Johnson Company

See the full list of April FDA clearances.

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