510(k) K881769

HJD CALCAR REPLACEMENT PROSTHESIS by Richards Medical Co., Inc. — Product Code JDI

K881769 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "HJD CALCAR REPLACEMENT PROSTHESIS". The FDA issued a decision of Substantially Equivalent on June 22, 1988. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Richards Medical Co., Inc. has at least 10 other 510(k) clearances on record.