Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF And TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD

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

Corin Ltd.

The following data is part of a premarket notification filed by Corin Ltd. with the FDA for Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ Plus Acetabular Shell, Metafix™ Hip System, Trifit™ Cf And Ts Hip Systems, Taperfit™ Hip System, Revival™ Modular Hip System, Minihip™, Trinity™ Dual Mobility, Mobilit, Bipolar-i, Omni Mod.

Pre-market Notification Details

Device IDK201657
510k NumberK201657
Device Name:Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF And TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant Corin Ltd. 480 Paramount Drive Raynham,  MA  02767
ContactChristina Rovaldi
CorrespondentRobert A Poggie
BioVera Inc. 65 Promenade Saint-Louis Notre-dame-de-l’ile-perrot,  CA J7v 7p2
Product CodeLZO  
Subsequent Product CodeJDI
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeLPH
Subsequent Product CodeMEH
Subsequent Product CodeOQG
Subsequent Product CodeOQI
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-18
Decision Date2021-07-28

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