16 spine devices receive FDA 510(k) clearance in January

Written by Laura Dyrda | February 22, 2018 | Print  |

The FDA granted 16 spine-related device clearances in January 2018.

1. K2M Navigation Instruments from K2M.


2. Stryker iVAS Elite Inflatable Vertebral Augmentation System from Stryker.


3. Matisse Anterior Cervical Interbody Fusion Cage System, Ti-PEEK from CTL Medical.


4. Arbor External Fixation System from Globus Medical.


5. Spineology Navigation Instruments from Spineology.


6. Wiltrom Spinal Fixation System from Wiltrom.


7. TiGer Shark System from ChoiceSpine.


8. ChoiceSpine Laminoplasty Fixation System from ChoiceSpine.


9. Cervical Spinal Truss System Interbody Fusion Device from 4Web.


10. Reliance Lumbar IBF System from Reliance Medical Systems.


11. Navigated Infinity Instruments from Medtronic Sofamor Danek.


12. Titanium TL Curved Posterior Lumber Cage from Stryker.


13. Everest Spinal System from K2M.


14. SeaSpine Cabo Anterior Cervical Plate System from SeaSpine Orthopedics.


15. Juliet Ti LL from Spineart.


16. DeGen Medical E3 MIS Pedicle Screw System from Degen Medical.


More articles on spine devices:
Johnson & Johnson acquires robotic systems developer Orthotaxy: 5 things to know
Medtronic reports Q3 revenue at $7.3B, 1% increase: 5 things to know
19 spine, orthopedic device companies to impact the industry in 2018


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