510(k) K192428

AFX Femoral Implant with Inserter by Cayenne Medical — Product Code MBI

K192428 is an FDA 510(k) premarket notification submitted by Cayenne Medical for the device "AFX Femoral Implant with Inserter". The FDA issued a decision of Substantially Equivalent on October 5, 2019. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Cayenne Medical has at least 10 other 510(k) clearances on record.