EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM

EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM is an FDA 510(k)-cleared medical device (K131298) manufactured by Exactech, 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 25, 2013. Regulation: 8.