MILLAR/GALANTE PRECOATED TOTAL KNEE

MILLAR/GALANTE PRECOATED TOTAL KNEE is an FDA 510(k)-cleared medical device (K853661) 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 December 8, 1985. Regulation: 8.