510(k) K203779

Symmetric Total Knee System by Signal Medical Corporation — Product Code MBH

K203779 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 June 10, 2021. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Signal Medical Corporation has at least 1 other 510(k) clearance on record.