EVOS Small Fragment Upper Extremity Plates Line Additions

Plate, Fixation, Bone

Smith & Nephew, Inc

The following data is part of a premarket notification filed by Smith & Nephew, Inc with the FDA for Evos Small Fragment Upper Extremity Plates Line Additions.

Pre-market Notification Details

Device IDK190253
510k NumberK190253
Device Name:EVOS Small Fragment Upper Extremity Plates Line Additions
ClassificationPlate, Fixation, Bone
Applicant Smith & Nephew, Inc 1450 Brooks Road Memphis,  TN  38116
ContactShereen Bienz
CorrespondentShereen Bienz
Smith & Nephew, Inc 1450 Brooks Road Memphis,  TN  38116
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-07
Decision Date2019-03-11
Summary:summary

NIH GUDID Devices

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