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

Spinal Tech

DoctorThe Food and Drug Administration granted 31 spine- and orthopedic-related medical device clearances in July.

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1. Pipeline Total Hip System from Pipeline Orthopedics.

 

2. Affix Spinous Process Plate System from NuVasive.

 

3. ArthroCare Turbinator Wand from ArthroCare.

 

4. Y-Knot Flex All-Suture Anchor form Linvatec.

 

5. Dynasty Acetabular System With Ceramic from Wright Medical Technology.

 

6. Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate from Exactech.

 

7. Lapidus Plate, Inline Fusion Plate, from Biomet.

 

8. Arthrex Distal Radius Plate System from Arthrex.

 

9. Transcorp ACIF System from Transcorp.

 

10. Prophecy Infinity Preoperative Navigation Alignment Guides from Wright Medical Technology.

 

11. MectaLIF from MEDACTA International.

 

12. FuseForce Implant System from Solana Surgica.

 

13. Nexus Anterior Cervical Plate System from Core-Nexus.

 

14. Facet Fixx from Nexxt Spine.

 

15. Lanx Fusion System from Lanx.

 

16. 611 Ankle Fusion Nail from Tornier.

 

17. Life Spine Plateau Spacer System from Life Spine.

 

18. iTotal Cruciate Retaining Knee Replacement System from ConforMIS.

 

19. Navigation Pin from Evergreen Orthopedic Research Lab.

 

20. Stabiliz Fixation System-SPL Locking Screw from Stabiliz Orthopaedics.

 

21. 4MM & 5MM Full Radius Blade Plus from DePuy Mitek.

 

22. Reform Pedicle Screw System from Spinal USA.

 

23. Capstone Spinal System from Medtronic Sofamor Danek.

 

24. Jones-Fx Fracture System from Instratek.

 

25. Healix Advance Knotless BR Anchor from DePuy Mitek.

 

26. GMK Revision Extension from Medacta International.

 

27. Sustain and Sustain Radiolucent Spacers from Globus Medical.

 

28. MultiFix Knotless Fixation Device from ArthroCare.

 

29. SpineVision Lumis Cannulated PolyAxial Pedicle Screw Fixation System from SpineVision.

 

30. Coalition Spacer from Globus Medical.

 

31. Athrex SpeedCinch from Arthrex.

 

More Articles on Orthopedic Devices:
40 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in May
35 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in April
31 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in March

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