24 orthopedic devices receive FDA 510(k) clearance in January 2017

Spinal Tech

The FDA granted 24 orthopedic devices in January 2017.

1. Taps for Resorbable Screws from Synthes.

 

2. Altus Spine Interbody Fusion System from Altus Partners.

 

3. Facilis Spinal System from Baui Biotech.

 

4. StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis from Biomet.

 

5. dynaMX Compression Plate from MX Orthopedics.

 

6. Anatomic Total Knee System from Amplitude.

 

7. Orthofix Chimaera Hip Fracture System – Trochanteric Nailing System from Orthofix.

 

8. Poseidon OCT Spinal Fixation System from Medyssey USA.

 

9. GEO Bone Screw System from Gramercy Extremity Orthopedics.

 

10. MOTO Partial Knee System from Medacta.

 

11. Siconus SI Joint Fixation System from Camber Spine Technologies.

 

12. Osteo-WEDGE II Open Wedge Bone Locking Plate System from Graham Medical Technologies.

 

13. Humelock Reverse Shoulder from FX Solutions.

 

14. Ayers Rock Cervical Interbody Fusion System from Spineway.

 

15. Jazz Frame System from Implanet.

 

16. Legion Cone System from Smith & Nephew.

 

17. Pass LP Spinal System from Medicrea.

 

18. Elite Expandable Interbody Fusion Device from Spineology.

 

19. SpineGuard DSG Zavation Screw System from SpineGuard.

 

20. OrthAlign Plus System from OrthAlign.

 

21. Ortholoc 3Di Ankle Fracture Plating System from Wright Medical Technology.

 

22. SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides from Materialise.

 

23. CrossFT Knotless Suture Anchor with Disposable Driver from ConMed Corp.

 

24. NovaBone IRM from NovaBone Products.

 

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