aprevo Intervertebral Body Fusion Device

aprevo Intervertebral Body Fusion Device is an FDA 510(k)-cleared medical device (K202034) manufactured by Carlsmed, 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 December 2, 2020. Regulation: 8.