FREEMAN UNI-COMPARTMENTAL KNEE

FREEMAN UNI-COMPARTMENTAL KNEE is an FDA 510(k)-cleared medical device (K853268) manufactured by Protek, 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 3, 1985. Regulation: 8.