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Exactech, Inc.
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EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13 is an FDA 510(k)-cleared medical device (K101761) manufactured by Exactech, 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 20, 2010. Regulation: 8.