IO Expandable Lumbar Interbody Fusion System

IO Expandable Lumbar Interbody Fusion System is an FDA 510(k)-cleared medical device (K210800) 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 August 19, 2021. Regulation: 8.