LEGION Inserts With JRNY Lock

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, 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 Inserts With Jrny Lock.

Pre-market Notification Details

Device IDK200407
510k NumberK200407
Device Name:LEGION Inserts With JRNY Lock
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
ContactKonrad Wolfmeyer
CorrespondentKonrad Wolfmeyer
Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-19
Decision Date2020-03-13

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