ARIX Ankle 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 System.

Pre-market Notification Details

Device IDK193616
510k NumberK193616
Device Name:ARIX Ankle 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 08378
ContactJonghwan Kim
CorrespondentJonghwan Kim
Jeil Medical Corporation 702, 703, 704, 705, 706, 804, 805,807,812-ho ,55, Digital-ro34-gil, Guro-gu Seoul,  KR 08378
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-26
Decision Date2020-03-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809282819841 K193616 000

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