
Exactech, Inc.
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OPTETRAK B-SERIES TOTAL KNEE SYSTEM is an FDA 510(k)-cleared medical device (K010434) 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 March 12, 2001. Regulation: 8.