FlareHawk TiHawk9 Interbody Fusion System

FlareHawk TiHawk9 Interbody Fusion System is an FDA 510(k)-cleared medical device (K201367) manufactured by Integrity Implants, 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 September 22, 2020. Regulation: 8.