510(k) K123907

PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, by Biomet Manufacturing Corp — Product Code KRR

K123907 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,". The FDA issued a decision of Substantially Equivalent on September 3, 2013. The device falls under product code KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3540. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.