MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is an FDA 510(k)-cleared medical device (K232154) 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 September 10, 2023. Regulation: 8.