Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks

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 Patient Matched Cutting Blocks.

Pre-market Notification Details

Device IDK200826
510k NumberK200826
Device Name:Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-30
Decision Date2020-04-24

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