LEGION Porous CR Narrow Femoral Components

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

Smith & Nephew, Inc.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Legion Porous Cr Narrow Femoral Components.

Pre-market Notification Details

Device IDK210566
510k NumberK210566
Device Name:LEGION Porous CR Narrow Femoral Components
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant Smith & Nephew, Inc. 1450 Brooks Road Memphis,  TN  38116
ContactMichelle Huettner
CorrespondentMichelle Huettner
Smith & Nephew, Inc. 1450 Brooks Road Memphis,  TN  38116
Product CodeMBH  
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-26
Decision Date2021-03-25

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