510(k) K934354

LACEY ALL POLYETHYLENE TIBIAL COMPONENT by Dow Corning Wright — Product Code JWH

K934354 is an FDA 510(k) premarket notification submitted by Dow Corning Wright for the device "LACEY ALL POLYETHYLENE TIBIAL COMPONENT". The FDA issued a decision of Substantially Equivalent on June 3, 1994. 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. Dow Corning Wright has at least 10 other 510(k) clearances on record.