BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX

BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX is an FDA 510(k)-cleared medical device (K960425) manufactured by Endotec, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 1996. Regulation: 8.