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Cayenne Medical, Inc.
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APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM is an FDA 510(k)-cleared medical device (K083612) manufactured by Cayenne Medical, 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 3, 2009. Regulation: 8.