aprevo® posterior/transforaminal lumbar interbody fusion device

aprevo® posterior/transforaminal lumbar interbody fusion device is an FDA 510(k)-cleared medical device (K250987) 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 June 29, 2025. Regulation: 8.