Smith & Nephew, Inc. R3™ Constrained Liner

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

Smith & Nephew, Inc.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew, Inc. R3™ Constrained Liner.

Pre-market Notification Details

Device IDK162641
510k NumberK162641
Device Name:Smith & Nephew, Inc. R3™ Constrained Liner
ClassificationProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Applicant Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
ContactNatalie P. Williams
CorrespondentDongeun Kim
Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
Product CodeKWZ  
CFR Regulation Number888.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-22
Decision Date2017-06-19
Summary:summary

NIH GUDID Devices

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