510(k) K823729

SPECTRON METAL BACK ACETABULAR COMPONENT by Richard'S Medical Equip., Inc. — Product Code JDI

K823729 is an FDA 510(k) premarket notification submitted by Richard'S Medical Equip., Inc. for the device "SPECTRON METAL BACK ACETABULAR COMPONENT". The FDA issued a decision of Substantially Equivalent on January 21, 1983. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Richard'S Medical Equip., Inc. has at least 10 other 510(k) clearances on record.