31 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in March

Spinal Tech

The Food and Drug Administration granted 31 orthopedic- and spine-related clearances in March. 1. DePuy Gription TF 5.5MM Sterile Locking Screws from DePuy Orthopaedics.

2. TM Ardis Interbody System Inserter from Zimmer Trabecular Metal Technology.

3. Inbone Total Ankle Systems from Wright Medical Technology.

4. SP2 Femoral Locking Nail, SP2 Tibial Locking Nail from Biomecanica Insria E Comerico.

5. Superior Lateral Variax Clavicle Plate from Stryker Trauma.

6. Solus Anterior Lumbar Interbody Fusion System from Alphatec Spine.

7. Nautilus Spinal System from Life Spine.

8. Grafton II from Medtronic Sofamor Danek.

9. Trinity Acetabular System from Corin Medical.

10. GSO GS1 Cannulated Screw System from Gold Standard Orthopaedics.

11. AAP Radius Set 2.5 from AAP Implantate.

12. Silex Sacroiliac Joint Fusion System from X-Spine Systems.

13. S4 Spinal System from Aesculap Implant Systems.

14. Zimmer Nexel Total Elbow from Zimmer.

15. Ellipse Occipito-Cervico-Thoracic Spinal System and Capitol Implants from Globus Medical.

16. Paragon Hip System from Global Manufacturing Technology.

17. Fem-Felx (II) Femoral Access Cannula with Duraflo Coating from Edwards LifeSciences.

18. Lanx Fusion System from Lanx.

19. All-Suture Anchor Twist Drill from Smith & Nephew.

20. Acumed Cannulated Screw System from Acumed.

21. Optetrak Logic Porous Femoral Component from Exactech.

22. Vanguard XP Knee System from Biomet Manufacturing.

23. Axsos Proximal Lateral Tibia Long Plates from Stryker Trauma.

24. OIC Distal Radius Plating System, OIC Clavicle Plating System from the Orthopaedic Implant Company.

25. Advance Total Knee System-Patella from Wright Medical Technology.

26. Pass OCT Spinal System from Medicrea Interventional.

27. Spineology PEEK Lumbar Interbody Fusion Device from Spineology.

28. Variax 2 Compression Plating System from Stryker Trauma.

29. Anatomic PEEK Cervical Fusion System Cornerstone from Medtronic Sofamor Danek.

30. Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps from Medtronic Navigation.

31. Balanced Knee System High Flex from Ortho Development.

More Articles on FDA Clearances:

41 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in February

25 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in January

38 Orthopedic & Spine Devices Receive FDA 510(k) Clearances in December


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