Smith & Nephew VISIONAIRE Adaptive Guides

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 Smith & Nephew Visionaire Adaptive Guides.

Pre-market Notification Details

Device IDK170282
510k NumberK170282
Device Name:Smith & Nephew VISIONAIRE Adaptive Guides
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Smith & Nephew, Inc 7135 Goodlett Farms Parkway Cordova,  TN  38016
ContactBrad Sheals
CorrespondentBrad Sheals
Smith & Nephew, Inc 7135 Goodlett Farms Parkway Cordova,  TN  38016
Product CodeJWH  
Subsequent Product CodeMBH
Subsequent Product CodeOOG
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-30
Decision Date2017-05-22
Summary:summary

NIH GUDID Devices

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