27 orthopedic devices receive FDA 510(k) clearance in August

Laura Dyrda -   Print  |

The FDA approved 27 orthopedic devices in August.


1. Nadia SI Fusion System from Ilion Medical.
2. Orion Spinal System from Orion Biotech.
3. Mondrian Lumbar Interbody Fusion Cage System from CTL Medical Corporation.
4. Spartan Hip Stem from Signature Orthopaedics.
5. Uniko PointCloud Knee Instruments from Nik Orthopedics.
6. Exeter V40 Femoral Stem, Exeter X3 RimFit Cup from Howmedica Osteonics.
7. Corin Optimized Positioning System Femoral form Corin USA.
8. Verasense for Exactech Equinoxe Size 38mm from OrthoSensor.
9. GS Medical AnyPlus PEEK Cage System from GS Medical.
10. Modulif-A Anterior Lumbar Interbody Fusion System from Spinal Stability.
11. K2M Navigation Instruments from K2M.
12. Aurora Anterior Lumbar Plate System from Prism Surgical Design.
13. Adaptix Interbody System with Titan nanoLOCK Surface Technology from Medtronic Sofamor Danek.
14. CD Horizon Fenestrated Screw Set, System, Kyphon HV-R Bone Cement from Medtronic.
15. Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer from Life Spine.
16. Medina Anterior Cervical Plate System from Alliance Partners.
17. Precice Bone Transport System from NuVasive Specialized Orthopedics.
18. Monterey AL Interbody System from Stryker.
19. Hercules Suture Anchor System from In2Bones USA.
20. CoFix System from Paradigm Spine.
21. Smart Toe II, X Fuse from Stryker.
22. Arthrex SwiveLock Anchor from Arthrex.
23. Anser Clavicle Pin from Baat Medical Products.
24. Confidence Spinal Cement System from DePuy Spine.
25. Vector Hammertoe Correction System from Nvision Biomedical Technologies.
26. CarboClear Pedicle Screw System, CarboClear II Pedicle Screw System from CarboFix Orthopedics.
27. Cervical Plate System from Eminent Spine.

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