510(k) K080199

SYMMETRIC TOTAL KNEE SYSTEM by Signal Medical Corporation — Product Code JWH

K080199 is an FDA 510(k) premarket notification submitted by Signal Medical Corporation for the device "SYMMETRIC TOTAL KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 3, 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. Signal Medical Corporation has at least 1 other 510(k) clearance on record.