FDA Clears 36 Orthopedic and Spine Devices in December

The FDA issued 36 orthopedic- and spine-related 510(k) clearances in December, according to a report by the FDA.

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1. Duowedge Synthetic Bone Substitute from Kasios

2. Pivotec Lumbar Interbody Fusion Device from Captiva Spine

3. Xia 4.5 Spinal System from Stryker Spine

4. Bollard Miniplate Skeletal Anchorage System from Tita-Link

5. Arrowbone-A, Arrowbone-B from Brainbase Corp.

6. Afghan External Fixator from Smith & Nephew

7. Modification of Lanx Spinal Fixation System from Lanx

8. Synthes Matrixmandible Subcondylar Plates from Synthes

9. Smith & Nephew Twin fix Ultra PK Suture Anchor from Smith & Nephew

10. Life Spine Stand-Alone Spacer System from Life Spine

11. Modification to CD Horizon Spinal System from Medtronic Sofamor Danek

12. Orthocor Knee System from Orthocor Medical

13. Smith & Nephew Journey Select Knee System from Smith & Nephew

14. Iduo Bicompartmental Knee Repair System from Conformis

15. Modification of Caspian Spinal System from K2M

16. Depuy Pinnacle with Gription Acetabular Cups from Depuy Orthopedics

17. Smith & Nephew Knotless Instability Anchor from Smith & Nephew

18. Orthocor Knee System, Median, Large, X-Large from Orthocor Medical

19. Legion PorousPlus HA Primary Femoral Components from Smith & Nephew

20. Pathway IVB/VBR from Custom Spine

21. Choice Spine Anterior Cervical Plate System from Choice Spine

22. Synthes 2.4MM LCP Volar Column Distal Radius Plates from Synthes

23. Alpha-BSM, Beta-BSM, Gamma-BSM Equabone from Etex Corp.

24. Paradis Vaso Shield from Spinemedica

25. Synthes Matrix System from Synthes

26. Stabili ERX Bobe Cement Model 1135  Stabilit Vertibral Augmentation System for use with Stabilit ERX Bone Cement from DFine

27. AVS PL Peek Spacers from Stryker Corp.

28. Interfuse Invertebral Body Fusion Device Model 9076 From Vertebral Technologies

29. Restoration ADM System X3 Acetabular from Howmedica Osteonics

30. Sic Brevetti SRL Device for Sternal Syntesis from Sic Brevetti SRL

31. Integra Total Wrist Fusion System from Integra Lifesciences

32. Bard Permafix Fixation System from C.R. Bard

33. CerviCore Corpectomy Cage from Verticor

34. Dyna Locking IM Nail from U&I Corp.

35. Vertex Reconstruction System and Vertex Select Reconstruction System from Medtronic Sofamor Danek

36. Patriot Transcontinental LLIF Spacer from Globus Medical

See the full list of FDA clearances.

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