Corin TriFit CF Hip Stem

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

Corin USA Limited

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

Pre-market Notification Details

Device IDK173880
510k NumberK173880
Device Name:Corin TriFit CF Hip Stem
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant Corin USA Limited 12750 Citrus Park Lane Tampa,  FL  33625
ContactRachel King
CorrespondentRachel King
Corin USA Limited 12750 Citrus Park Lane Tampa,  FL  33625
Product CodeMEH  
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeLPH
Subsequent Product CodeLZO
Subsequent Product CodeMBL
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-21
Decision Date2018-04-11
Summary:summary

NIH GUDID Devices

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