31 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in February

Spinal Tech

The Food and Drug Administration granted 31 spine- and orthopedic-related medical device clearances in February.

1. DeRoyal Spine Spacer System from DeRoyal Industries.

 

2. Juliet LL Lateral Lumbar Cage from Spineart.

 

3. Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System from Smith & Nephew.

 

4. 4.5MM Healix Advance BR Anchor from DePuy Mitek.

 

5. Zimmer Personal The Personalized Knee System 14X + 30 MM Tapered Stem Extension from Zimmer.

 

6. Integrity Spinal Care System from Integrity Life Sciences.

 

7. NB3D Bone Void Filler from Pioneer Surgical Technology.

 

8. Duocentric Reversed Shoulder Prosthesis from Aston Medical.

 

9. Opticage Interbody Fusion Device Model Series 9070 from Interventional Spine.

 

10. Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis from Synchro Medical.

 

11. C-Plus from Pioneer Surgical Technology.

 

12. Equinoxe Extra Short Humeral Head from Exactech.

 

13. Ahbpress Absorbable Hemostatic Bone Putty from Orthocon.

 

14. C-Box PEEK Cervical IBF from Innovasis.

 

15. Exactech Acapella One Cervical Spacer System from Exactech.

 

16. Klassic HD Extended Offset Femoral Head from Total Joint Orthopedics.

 

17. Conventus DRS from Conventus Orthopaedics.

 

18. KASM Knee Articulating Spacer Molds from Ortho Development.

 

19. Dynamic Anterior Cervical Plate System from Globus Medical.

 

20. INBONE Total Ankle from Wright Medical Technology.

 

21. Freedom PCK Components from MAXX Orthopedics.

 

22. Novohip Total Hip System from Navigant Consulting.

 

23. Extrimilock Ankle Plating System from Osteomed.

 

24. Pression Spinal Fixation System from Nexus Spine.

 

25. CD Horizon Spinal System Growth Rod Set from Medtronic.

 

26. QSI Q System Arthroscopes from Orthopedic Sciences.

 

27. ArthroSurface Toemotion from ArthroSurface.

 

28. Emerge Medical Bone Plate System from Emerge Medical.

 

29. Ellipse Magec Spinal Bracing and Distraction System from Ellipse Technologies.

 

30. Arthrex iBalance TKA System from Arthrex.

 

31. ICONIX All Suture Anchors from Stryker Corp.

 

More Articles on FDA Clearances:
35 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in January
44 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in December
10 Spine Devices Receive FDA 510(k) Clearance in November

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