510(k) K930190

ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP by Dow Corning Wright — Product Code JWH

K930190 is an FDA 510(k) premarket notification submitted by Dow Corning Wright for the device "ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP". The FDA issued a decision of Substantially Equivalent on August 2, 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.