ARIX Ankle Distal Tibia 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 Ankle Distal Tibia System.

Pre-market Notification Details

Device IDK202912
510k NumberK202912
Device Name:ARIX Ankle Distal Tibia 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  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2020-10-29

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.