Navigated Anterolateral Disc Prep Instruments

Navigated Anterolateral Disc Prep Instruments is an FDA 510(k)-cleared medical device (K211441) manufactured by Medtronic Sofamor Danek USA, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 8, 2021. Regulation: 8.