510(k) K904879

BEUCHEL-PAPPAS GLENOID COMPONENT by Endotec, Inc. — Product Code KWS

K904879 is an FDA 510(k) premarket notification submitted by Endotec, Inc. for the device "BEUCHEL-PAPPAS GLENOID COMPONENT". The FDA issued a decision of Substantially Equivalent on January 28, 1991. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Endotec, Inc. has at least 10 other 510(k) clearances on record.