36 orthopedic, spine devices receive FDA 510(k) clearance in December

Written by Laura Dyrda | January 10, 2019 | Print  |

The FDA cleared 36 orthopedic- and spine-related devices in December 2018.

1. C-Zero Pedicle Screw System, Freedom Pedicle Screw System from Signature Orthopaedics.

2. Arthrex SwiveLock Anchors from Arthrex.

3. Met One Czar Anterior Cervical Plate System from Met One Technologies.

4. TruMatch Graft Cage – Long Bone from Synthes USA.

5. Revel Spacers from Globus Medical.

6. DePuy Synthes T-PAL Spacer System from DePuy Synthes Spine.

7. Patriot Lumbar Spacers, Sustain Spacers from Globus Medical.

8. Arthrex Fracture Adapter Hemi Shoulder Prosthesis from Arthrex.

9. Curiteva Lumbar Interbody Fusion System from Curiteva.

10. Life Spine Resolute Threaded Cage System from Life Spine.

11. Zimmer Biomet Select Ceramic Heads from Zimmer.

12. Glenoid Polyaxial Non-locking Screws from Medacta.

13. Affixus Natural Nail System Humeral Nail from Zimmer.

14. MectaLIF Posterior Extension from Medacta.

15. Renovis Tesera C/Tesera SC Anterior Cervical Fusion System from Renovis.

16. Avenir Complete Hip System from Zimmer.

17. Evolution Stemmed CS Femur from MicroPort Orthopedics.

18. Leucadia Autolok Pedicle Screw System from ClearView Orthopedic Development.

19. HipCheck from Stryker.

20. Arthrex Compression FT Screws from Arthrex.

21. Latitude EV Total Elbow Arthroplasty from Tornier.

22. Pyrenees Cervical Plate System, Blue Ridge Cervical Plate System, Zoark Cervical Plate System, Cayman Thoracolumbar and Buttress Plate Systems from K2M.

23. Lucent from Spinal Elements.

24. OIC Suture Anchor System from The Orthopaedic Implant Company.

25. DePuy Synthes Trauma Orthopedic Nail Implants from DePuy Synthes.

26. Distal Radius Plating System from Miami Device Solutions.

27. Integra Salto Total Ankle System from Ascension Orthopedics.

28. Helix Compression Screw System from Nvision Biomedical Technologies.

29. Salvo Spine System from Spine Wave.

30. Aurora Screw System from MiRus.

31. Mega Plus Spine System from BK Meditech.

32. IlluminOss Photodynamic Bone Stabilization System from IlluminOss Medical.

33. Affixus Hip Fracture Nail from Biomet.

34. OpenLoc-L Spinal Fixation System from L&K Biomed.

35. CoreLink F3D Lateral System from CoreLink.

36. Anax OCT Spinal System from U&I Corporation.

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SeaSpine's 2018 revenue increases 8.5% to $143M: 5 financial report details
Stryker organic sales growth increases for 6 years

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