Addivation Medical Cervical Interbody System

Addivation Medical Cervical Interbody System is an FDA 510(k)-cleared medical device (K190291) manufactured by Addivation Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 29, 2019. Regulation: 8.