EXACTECH HUMERAL SHOULDER PROSTHESIS

EXACTECH HUMERAL SHOULDER PROSTHESIS is an FDA 510(k)-cleared medical device (K905577) 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 March 11, 1991. Regulation: 8.