MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM

MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM is an FDA 510(k)-cleared medical device (K942263) 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 July 10, 1995. Regulation: 8.