GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM

GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM is an FDA 510(k)-cleared medical device (K130317) manufactured by Genesys Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 10, 2013. Regulation: 8.