CORIN METAFIX HIP STEM

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

CORIN USA

The following data is part of a premarket notification filed by Corin Usa with the FDA for Corin Metafix Hip Stem.

Pre-market Notification Details

Device IDK131952
510k NumberK131952
Device Name:CORIN METAFIX HIP STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant CORIN USA 5670 W. CYPRESS ST. SUITE C Tampa,  FL  33607
ContactLucinda Gerber
CorrespondentLucinda Gerber
CORIN USA 5670 W. CYPRESS ST. SUITE C Tampa,  FL  33607
Product CodeLZO  
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeMEH
Subsequent Product CodeOQI
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-27
Decision Date2013-12-16
Summary:summary

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