DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM

DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM is an FDA 510(k)-cleared medical device (K141599) manufactured by Medtronic Sofamor Danek USA, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 20, 2015. Regulation: 8.