17 spine devices receive FDA 510(k) clearance in December

Written by Laura Dyrda | January 10, 2020 | Print  |

The FDA cleared 17 spine-related devices in December.

1. Pantheon Spinal Pontus Interbody Fusion Device from Pantheon Spinal.

2. Corelink Navigation Instruments from Corelink.

3. Genesys Spine 3DP Lumbar Interbody System from Genesys Spine.

4. Spinal Elements Navigated Instruments from Spinal Elements.

5. Xvision Spine System from Augmedics.

6. Southern Implants PEEK Abutments from Southern Implants.

7. Vital Navigation System from Zimmer Biomet Spine.

8. Stand-Alone ALIF Titanium System from Life Spine.

9. 4CIS Marlin PEEK ACIF Cage from Solco Biomedical.

10. SeaSpine Beachside System from SeaSpine Orthopedics.

11. Tracker Kyphoplasty System from GS Medical.

12. Spinalytics from Optima Health Solutions International.

13. Percusys Plus Pedicle Screw System from Joimax.

14. Fortilink Interbody fusion Device from Pioneer Surgical Technology.

15. Corridor Fixation System from Globus Medical.

16. Invictus Spinal Fixation System from Alphatec Spine.

17. Ziehm Vision FD from Ziehm Imaging.

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