510(k) K092198

CORMET CEMENTLESS RESURFACING FEMORAL HEAD by Corin USA — Product Code KXA

K092198 is an FDA 510(k) premarket notification submitted by Corin USA for the device "CORMET CEMENTLESS RESURFACING FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on April 15, 2010. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Corin USA has at least 10 other 510(k) clearances on record.