Revival Modular Hip Stem

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

Corin USA Limited

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

Pre-market Notification Details

Device IDK191374
510k NumberK191374
Device Name:Revival Modular Hip Stem
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
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 CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-23
Decision Date2019-07-22
Summary:summary

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