510(k) K960425

BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX by Endotec, Inc. — Product Code JDI

K960425 is an FDA 510(k) premarket notification submitted by Endotec, Inc. for the device "BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX". The FDA issued a decision of Substantially Equivalent on October 3, 1996. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Endotec, Inc. has at least 10 other 510(k) clearances on record.