26 orthopedic devices receive FDA 510(k) clearance in February 2018

Written by Laura Dyrda | March 07, 2018 | Print  |

The FDA granted 26 orthopedic- and spine-related devices 510(k) clearance in February.

 

1. Zyston Strut Open Titanium Spacer System from Zimmer Biomet.

 

2. Tryptik2 C-Plate Anterior Cervical Plate System from Spineart.

 

3. The Plateau-LO Spacer System from Life Spine.

 

4. G-Beam Fusion Beaming System from Orthofix.

 

5. Cascadia Interbody System from K2M.

 

6. NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System; NuVasive AP Expandable XLIF System from NuVasive.

 

7. The Solstice OCT System from Life Spine.

 

8. Cavetto-SA Cervical Cage System from NeuroStructures.

 

9. Seurat Universal Pedicle Screw System from CTL Medical Corporation.

 

10. Talon DistalFix Humeral Nail from Orthopedic Designs North America.

 

11. Alta Anterior Cervical Interbody Spacer from Astura Medical.

 

12. SeaSpine Spinous Process System from SeaSpine Orthopedics.

 

13. Comprehensive Segmental Revision System from Zimmer Biomet.

 

14. Materialise TKA Guide System from Materialise.

 

15. RTS Lesser MTP Implant System from In2Bones USA.

 

16. Endoskeleton TAS Interbody Fusion, Endoskeleton TAS Hyperlordotic Interbody Fusion Device from Titan Spine.

 

17. Concorde Lift from Medos International.

 

18. Camber Spine Technologies Spira-V Open Matrix Corpectomy Cage from Camber Spine Technologies.

 

19. THP Hip Fracture Plating System from Zimmer Biomet.

 

20. Triathlon Total Knee System from Stryker Orthopaedics.

 

21. SeaSpine Mariner Pedicle Screw System from SeaSpine Orthopedics.

 

22. Remedy Acetabular Cup from Osteoremedies.

 

23. UNiD Spine Analyzer from Medicrea International.

 

24. Arthrex NanoSuture Anchor from Arthrex.

 

25. Eleos Bipolar Acetabular System from Onkos Surgical.

 

26. SeaSpine NewPort Spinal System from SeaSpine Orthopedics.

 

More articles on orthopedic devices:
6 trends for total joint replacements in the future
Average age for joint replacement drops: 5 key statistics
University of Iowa researchers create orthopedic surgery simulator: 4 insights

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