HLS UNI EVOLUTION & U-KNEETEC

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

TORNIER, INC.

The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Hls Uni Evolution & U-kneetec.

Pre-market Notification Details

Device IDK120262
510k NumberK120262
Device Name:HLS UNI EVOLUTION & U-KNEETEC
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant TORNIER, INC. 161, RUE LAVOISIER SAINT ISMIER CEDEX Montbonnot,  FR 38334
ContactStephanie Bernard
CorrespondentStephanie Bernard
TORNIER, INC. 161, RUE LAVOISIER SAINT ISMIER CEDEX Montbonnot,  FR 38334
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-27
Decision Date2012-07-25
Summary:summary

NIH GUDID Devices

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