510(k) K063515

TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE by Biomet Manufacturing, Inc. — Product Code HRY

K063515 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing, Inc. for the device "TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE". The FDA issued a decision of Substantially Equivalent on February 2, 2007. The device falls under product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3530. Biomet Manufacturing, Inc. has at least 10 other 510(k) clearances on record.