METS MODULAR DISTAL FEMUR

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

STANMORE IMPLANTS WORLDWIDE LTD

The following data is part of a premarket notification filed by Stanmore Implants Worldwide Ltd with the FDA for Mets Modular Distal Femur.

Pre-market Notification Details

Device IDK121029
510k NumberK121029
Device Name:METS MODULAR DISTAL FEMUR
ClassificationProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Applicant STANMORE IMPLANTS WORLDWIDE LTD 690 CANTON STREET SUITE 302 Westwood,  MA  02090
ContactNancy C Macdonald
CorrespondentNancy C Macdonald
STANMORE IMPLANTS WORLDWIDE LTD 690 CANTON STREET SUITE 302 Westwood,  MA  02090
Product CodeKRO  
CFR Regulation Number888.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-05
Decision Date2012-09-19
Summary:summary

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