ENDURO KNEE SYSTEM

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

AESCULAP IMPLANT SYSTEMS

The following data is part of a premarket notification filed by Aesculap Implant Systems with the FDA for Enduro Knee System.

Pre-market Notification Details

Device IDK101815
510k NumberK101815
Device Name:ENDURO KNEE SYSTEM
ClassificationProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Applicant AESCULAP IMPLANT SYSTEMS 3773 CORPORATE PWKY. Center Valley,  PA  18034
ContactKathy A Racosky
CorrespondentKathy A Racosky
AESCULAP IMPLANT SYSTEMS 3773 CORPORATE PWKY. Center Valley,  PA  18034
Product CodeKRO  
CFR Regulation Number888.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-30
Decision Date2010-12-20
Summary:summary

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