ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System

ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System is an FDA 510(k)-cleared medical device (K220115) 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 May 12, 2022. Regulation: 8.