510(k) K900638

P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT by Johnson & Johnson International — Product Code KWL

K900638 is an FDA 510(k) premarket notification submitted by Johnson & Johnson International for the device "P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT". The FDA issued a decision of Substantially Equivalent on April 30, 1990. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Johnson & Johnson International has at least 9 other 510(k) clearances on record.