
Exactech, Inc.
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EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM is an FDA 510(k)-cleared medical device (K093978) 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 May 10, 2010. Regulation: 8.