EQUINOXE EXTRA SHORT HUMERAL HEAD

EQUINOXE EXTRA SHORT HUMERAL HEAD is an FDA 510(k)-cleared medical device (K140063) 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 February 10, 2014. Regulation: 8.