510(k) K210566

LEGION Porous CR Narrow Femoral Components by Smith & Nephew, Inc. — Product Code MBH

K210566 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "LEGION Porous CR Narrow Femoral Components". The FDA issued a decision of Substantially Equivalent on Mar 25, 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. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.