510(k) K080528

E-POLY TIBIAL BEARINGS by Biomet Orthopedics, Inc. — Product Code JWH

K080528 is an FDA 510(k) premarket notification submitted by Biomet Orthopedics, Inc. for the device "E-POLY TIBIAL BEARINGS". The FDA issued a decision of Substantially Equivalent on June 17, 2008. 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. Biomet Orthopedics, Inc. has at least 10 other 510(k) clearances on record.