510(k) K073054

MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER by Cayenne Medical, Inc. — Product Code HWC

K073054 is an FDA 510(k) premarket notification submitted by Cayenne Medical, Inc. for the device "MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER". The FDA issued a decision of Substantially Equivalent on November 27, 2007. 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.