EVOLIS TOTAL KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

MEDACTA INTERNATIONAL, SA

The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Evolis Total Knee System.

Pre-market Notification Details

Device IDK081023
510k NumberK081023
Device Name:EVOLIS TOTAL KNEE SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego,  CA  92129
ContactNatalie J Kennel
CorrespondentNatalie J Kennel
MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego,  CA  92129
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-10
Decision Date2008-10-22
Summary:summary

NIH GUDID Devices

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