RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System

RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is an FDA 510(k)-cleared medical device (K232348) 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 October 26, 2023. Regulation: 8.