ARIX Clavicle System

Plate, Fixation, Bone

Jeil Medical Corporation

The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Arix Clavicle System.

Pre-market Notification Details

Device IDK180972
510k NumberK180972
Device Name:ARIX Clavicle System
ClassificationPlate, Fixation, Bone
Applicant Jeil Medical Corporation 702,703,704,705,706,804,805,807,812,815-ho,55 Digital-ro34-gil, Guro-gu Seoul,  KR 08378
ContactSeungyong Lee
CorrespondentSeungyong Lee
Jeil Medical Corporation 702,703,704,705,706,804,805,807,812,815-ho,55 Digital-ro34-gil, Guro-gu Seoul,  KR 08378
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-13
Decision Date2018-10-03
Summary:summary

NIH GUDID Devices

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