INTEGRATE -C Interbody Fusion System

INTEGRATE -C Interbody Fusion System is an FDA 510(k)-cleared medical device (K222004) manufactured by Happe Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 27, 2023. Regulation: 8.