510(k) K885036

POROUS COATED GENESIS FEMORAL COMPONENT by Richards Medical Co., Inc. — Product Code JWH

K885036 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "POROUS COATED GENESIS FEMORAL COMPONENT". The FDA issued a decision of SN on April 19, 1989. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Richards Medical Co., Inc. has at least 10 other 510(k) clearances on record.