28 orthopedic, spine device companies receive FDA 510(k) clearance in December 2016

Spinal Tech

The FDA granted 28 orthopedic- and spine- related device clearances in December 2016.

1. Lospa Modular Knee System from Corentec.


2. OIC Cervical PEEK Spacer from The Orthopaedic Implant Company.


3. PS2 Knee System from Consensus Orthopedics.


4. Cerasorb Ortho Foam from Curasan.


5. Destiknee Total Knee System from Meril Healthcare Private.


6. Confidence High Viscosity Spinal Cement, Viper and Expedium fenestrated screw systems from Medos International.


7. Sphynx from Eden Spine.


8. neon3 universal OCT spinal stabilization from Ulrich GMBH & Co.


9. Arthrex iBalance UKA System Vitamin E Tibial Bearing from Arthrex.


10. The Small Plateau (Plateau-C) Spacer System from Life Spine.


11. Oxinium DH Femoral Heads from Smith & Nephew.


12. Integrity-SI TM Fusion System from CoorsTek Medical.


13. ShurFit CpTi-HA ACIF Interbody Fusion System from Precision Spine.


14. Stryker Universal Mesh from Stryker.


15. IMSE Cervical Cage from The Institute of Musculoskeletal Science & Education.


16. Reliance Spinal Screw System from Reliance Medical Systems.


17. Ennovate Spinal System from Aesculap Implant Systems.


18. Medicrea International Anterior Cervical Locking Plate System from Medicrea.


19. Cougar LS Lateral Cage System and Cougar System from Medos.


20. SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device from SeaSpine.


21. Forza Spacer System, Pillar PEEK Spacer System, Pillar SA PEEK Spacer System, Skyhawk Lateral Interbody Fusion System from Orthofix.


22. Sterispine from Safe Orthopaedics.


23. Cetra Anterior Cervical Plate System from Orthofix.


24. Sovereign Spinal System from Medtronic Sofamor Danek USA.


25. Medline Unite Ankle Fracture Plating System from Medline.


26. Viper Prime additions to the Viper System from Medos international.


27. CyMedica e-vive System from CyMedica Orthopedics.


28. GMK Revision Femoral Distal Augmentation from Medacta.


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