510(k) K122463

APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W by Cayenne Medical, Inc. — Product Code MBI

K122463 is an FDA 510(k) premarket notification submitted by Cayenne Medical, Inc. for the device "APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W". The FDA issued a decision of Substantially Equivalent on October 11, 2012. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Cayenne Medical, Inc. has at least 10 other 510(k) clearances on record.