FlareHawk Interbody Fusion System

FlareHawk Interbody Fusion System is an FDA 510(k)-cleared medical device (K243116) manufactured by Integrity Implants Inc. Dba Accelus. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 20, 2025. Regulation: 8.