METS SMILES TOTAL KNEE REPLACEMENT

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 Smiles Total Knee Replacement.

Pre-market Notification Details

Device IDK120992
510k NumberK120992
Device Name:METS SMILES TOTAL KNEE REPLACEMENT
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 Received2012-04-02
Decision Date2012-09-05
Summary:summary

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