510(k) K942479

INTEGRAL CO-CR FEMORAL COMPONENT by Biomet, Inc. — Product Code JDG

K942479 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "INTEGRAL CO-CR FEMORAL COMPONENT". The FDA issued a decision of Substantially Equivalent on September 20, 1994. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Biomet, Inc. has at least 10 other 510(k) clearances on record.