RIGEL 3DR Anterior Cervical Interbody Fusion System

RIGEL 3DR Anterior Cervical Interbody Fusion System is an FDA 510(k)-cleared medical device (K200685) manufactured by MiRus, 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 June 10, 2020. Regulation: 8.