510(k) K012702

BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 by Endotec, Inc. — Product Code JWH

K012702 is an FDA 510(k) premarket notification submitted by Endotec, Inc. for the device "BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1". The FDA issued a decision of Substantially Equivalent on January 30, 2002. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Endotec, Inc. has at least 10 other 510(k) clearances on record.