CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS

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

CORIN U.S.A.

The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Corin Trinity Acetabular System With Extra-long Heads.

Pre-market Notification Details

Device IDK130343
510k NumberK130343
Device Name:CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant CORIN U.S.A. 5670 W CYPRESS STREET SUITE C Tampa,  FL  33607
ContactDiana L Martone
CorrespondentDiana L Martone
CORIN U.S.A. 5670 W CYPRESS STREET SUITE C Tampa,  FL  33607
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-11
Decision Date2013-05-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05055196968349 K130343 000
05055196968332 K130343 000
05055196937956 K130343 000
05055196937918 K130343 000
05055196937123 K130343 000
05055196926998 K130343 000

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