VISIONAIRE UK Patient Matched Cutting Guides

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

Smith & Nephew, Inc.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Visionaire Uk Patient Matched Cutting Guides.

Pre-market Notification Details

Device IDK211512
510k NumberK211512
Device Name:VISIONAIRE UK Patient Matched Cutting Guides
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
ContactLeah Hawkins
CorrespondentLeah Andre
Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
Product CodeHSX  
Subsequent Product CodeJWH
Subsequent Product CodeMBH
Subsequent Product CodeOOG
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-14
Decision Date2021-09-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885556780039 K211512 000
00885556779989 K211512 000

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