510(k) K083612

APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM by Cayenne Medical, Inc. — Product Code HWC

K083612 is an FDA 510(k) premarket notification submitted by Cayenne Medical, Inc. for the device "APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM". The FDA issued a decision of Substantially Equivalent on March 4, 2009. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Cayenne Medical, Inc. has at least 10 other 510(k) clearances on record.