ARIX Humerus 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 Humerus System.

Pre-market Notification Details

Device IDK172008
510k NumberK172008
Device Name:ARIX Humerus System
ClassificationPlate, Fixation, Bone
Applicant Jeil Medical Corporation 702.703.704.705.706.804.805.807.812-ho, 55 Digital-ro34-gil, Guro-gu Seoul,  KR 152-728
ContactSejin Ryu
CorrespondentSejin Ryu
Jeil Medical Corporation 702.703.704.705.706.804.805.807.812-ho, 55 Digital-ro34-gil, Guro-gu Seoul,  KR 152-728
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-03
Decision Date2017-12-01
Summary:summary

NIH GUDID Devices

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