510(k) K061681

REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT by Biomet Manufacturing Corp — Product Code HRY

K061681 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT". The FDA issued a decision of Substantially Equivalent on October 19, 2006. 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 Corp has at least 10 other 510(k) clearances on record.