MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE

MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE is an FDA 510(k)-cleared medical device (K880155) manufactured by Zimmer, 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 August 2, 1988. Regulation: 8.