EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT

EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT is an FDA 510(k)-cleared medical device (K931617) 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 June 13, 1994. Regulation: 8.