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 IDK183010
510k NumberK183010
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 Received2018-10-31
Decision Date2018-11-28
Summary:summary

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