ARIX Wrist 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 Wrist System.

Pre-market Notification Details

Device IDK191972
501k NumberK191972
Device Name:ARIX Wrist System
ClassificationPlate, Fixation, Bone
Applicant Jeil Medical Corporation 702,703,704,705,706,804,805,807,812,815-ho,55, Digital-ro 34-gil, Guro-gu Seoul,  KR 08378
ContactAhhyeon Woo
CorrespondentAhhyeon Woo
Jeil Medical Corporation 702,703,704,705,706,804,805,807,812,815-ho,55, Digital-ro 34-gil, Guro-gu Seoul,  KR 08378
Product CodeHRS  
Subsequent Product CodeHWC
Subsequent Product CodeLXT
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-24
Decision Date2019-11-12

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.