19 spine devices receive FDA 510(k) clearance in September

Written by Laura Dyrda | October 15, 2019 | Print  |

The FDA cleared 19 spine devices in September 2019.

1. Precision Spine Navigation Instrumentation from Precision Spine.

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

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

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

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

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

7. Hedron Cervical Spacers from Globus Medical.

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

9. Precice System from NuVasive Specialized Orthopedics.

10. Ti3Z Cervical Interbody System from Zavation Medical Products.

11. NuVasive ACP System from NuVasive.

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

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

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

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

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

17. TranS1 Interbody Fusion System from TranS1.

18. Hinged Laminoplasty System from Life Spine.

19. NuVasive NuvaLine from NuVasive.

More articles on spine surgery:
3 spine, orthopedic device company acquisitions
ChoiceSpine names 3 new exec leaders
31 orthopedic devices receive FDA 510(k) clearance

 

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