TRINITY ACETABULAR SYSTEM

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

CORIN USA

The following data is part of a premarket notification filed by Corin Usa with the FDA for Trinity Acetabular System.

Pre-market Notification Details

Device IDK131647
510k NumberK131647
Device Name:TRINITY ACETABULAR SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant CORIN USA 5670 W. CYPRESS ST. SUITE C Tampa,  FL  33607
ContactDiana L Martone
CorrespondentDiana L Martone
CORIN USA 5670 W. CYPRESS ST. SUITE C Tampa,  FL  33607
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-05
Decision Date2013-09-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05055343885123 K131647 000
05055343885116 K131647 000
05055343885109 K131647 000
05055343885093 K131647 000
05055343885086 K131647 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.