MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT

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 Modification To Journey Unicondylar Femoral Implant.

Pre-market Notification Details

Device IDK081351
510k NumberK081351
Device Name:MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis,  TN  38116
ContactNicholas B Tabrizi
CorrespondentNicholas B Tabrizi
SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis,  TN  38116
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-14
Decision Date2008-07-24
Summary:summary

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