510(k) K926257

ORTHOLOC ADVANTIM THICK TIBIAL BASE COMPONENT by Dow Corning Wright — Product Code JWH

K926257 is an FDA 510(k) premarket notification submitted by Dow Corning Wright for the device "ORTHOLOC ADVANTIM THICK TIBIAL BASE COMPONENT". The FDA issued a decision of Substantially Equivalent on May 18, 1993. 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.