DualX Lumbar Intervertebral Body Fusion Device

DualX Lumbar Intervertebral Body Fusion Device is an FDA 510(k)-cleared medical device (K192434) 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 14, 2019. Regulation: 8.