
Zimmer, Inc.
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MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE) is an FDA 510(k)-cleared medical device (K010685) 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 April 1, 2001. Regulation: 8.