aprevo® anterior lumbar interbody fusion device with interfixation

aprevo® anterior lumbar interbody fusion device with interfixation is an FDA 510(k)-cleared medical device (K222009) 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 November 21, 2022. Regulation: 8.