510(k) K881117

RESUBMITTING OF HJD TOTAL HIP SYSTEM by Richards Medical Co., Inc. — Product Code JDI

K881117 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "RESUBMITTING OF HJD TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on April 29, 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.