510(k) K050473

RBK PATELLA FEMORAL KNEE by Global Orthopaedic Technology, USA, Inc. — Product Code KRR

K050473 is an FDA 510(k) premarket notification submitted by Global Orthopaedic Technology, USA, Inc. for the device "RBK PATELLA FEMORAL KNEE". The FDA issued a decision of Substantially Equivalent on November 14, 2005. 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. Global Orthopaedic Technology, USA, Inc. has at least 2 other 510(k) clearances on record.