EVOS Large Fragment Plating System

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 Large Fragment Plating System.

Pre-market Notification Details

Device IDK203405
510k NumberK203405
Device Name:EVOS Large Fragment Plating System
ClassificationPlate, Fixation, Bone
Applicant Smith & Nephew, Inc. 1450 E Brooks Rd Memphis,  TN  38116
ContactThomas Fearnley
CorrespondentThomas Fearnley
Smith & Nephew, Inc. 1450 E Brooks Rd Memphis,  TN  38116
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-19
Decision Date2021-01-27

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