MobiliT Cup

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 Mobilit Cup.

Pre-market Notification Details

Device IDK191831
510k NumberK191831
Device Name:MobiliT Cup
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant Corin USA Limited 12750 Citrus Park Lane Tampa,  FL  33625
ContactSeverine Siracusa
CorrespondentSeverine Siracusa
Corin USA Limited 12750 Citrus Park Lane Tampa,  FL  33625
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-09
Decision Date2020-01-16

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