510(k) K994153

CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS by Corin USA — Product Code KXA

K994153 is an FDA 510(k) premarket notification submitted by Corin USA for the device "CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS". The FDA issued a decision of Substantially Equivalent on February 25, 2000. 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.