31 orthopedic devices receive FDA 510(k) clearance

Written by Laura Dyrda | October 08, 2019 | Print  | Email

The FDA cleared 31 orthopedic-related devices in September.

1. Precision Spine Navigation Instrumentation from Precision Spine.

2. USTAR II System from United Orthopedic Corporation.

3. Arthrex Tenodesis Button from Arthrex.

4. Republic Spine Restore Intervertebral Body Fusion System from Republic Spine.

5. Spira Open Matrix ALIF and LLIF from Camber Spine Technologies.

6. 4CIS PEEK PLIF Cage, $CIOS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pins PEEK from Solco Biomedical.

7. AccelFix Lumbar Interbody Fusion Cage System from L&K Biomed.

8. Sorrento Bone Graft Substitute form Xenco Medical.

9. Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set from Medtronic Sofamor Danek.

10. CrossOver Cross Connectors, DePuy Pulse Thoracolumbar Screw System from Medos International.

11. Hedron Cervical Spacers from Globus Medical.

12. iNSitu Bipolar Hip System from Teken Companies.

13. MectaLock Ti Suture Anchor from Medacta International.

14. Precice System from NuVasive Specialized Orthopedics.

15. Ti3Z Cervical Interbody System from Zavation Medical Products.

16. JuggerStitch Meniscal Repair Device from Biomet.

17. NuVasive ACP System from NuVasive.

18. Ali Interbody Fusion System from Raed M. Ali, MD., Inc.

19. Mercury Spinal System, Overwatch Spinal System from Spinal Elements.

20. Persona Revision Knee System from Zimmer.

21. Affinity – Variable Angle Distal Radius System from Industrias Medicas Sampedro.

22. Mont blanc & mont blanc MIS Spinal Systems from Spineway.

23. Genesys Spine Sacroiliac Joint Fusion System from Genesys Spine.

24. OMNI TiN Coated Apex Knee System from Omni LifeScience.

25. TranS1 Interbody Fusion System from TranS1.

26. Catalyst OrthoScience CSR Shoulder System from Catalyst OrthoScience.

27. Aptus Wrist Spanning Plates 2.5 from Medartis.

28. Hinged Laminoplasty System from Life Spine.

29. Mako Total Hip Application from Mako Surgical.

30. MiniMax from Medacta International.

31. NuVasive NuvaLine from NuVasive.

More articles on orthopedic devices:
Orthopedic devices market poised to surpass $55B—3 takeaways
Centinel Spine device for total disc replacement celebrates 18 years
Zimmer Biomet makes license deal worth up to $5M

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies here.