510(k) K081400

FANNING-PAPPAS MODULAR KNEE BEARING by Endotec, Inc. — Product Code JWH

K081400 is an FDA 510(k) premarket notification submitted by Endotec, Inc. for the device "FANNING-PAPPAS MODULAR KNEE BEARING". The FDA issued a decision of Substantially Equivalent on February 20, 2009. 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.