DualXSLIM(R) T/PLIF

DualXSLIM(R) T/PLIF is an FDA 510(k)-cleared medical device (K222203) manufactured by Amplify Surgical, Inc.. 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 17, 2022. Regulation: 8.