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 IDK170313
510k NumberK170313
Device Name:ARIX Ankle Distal Tibia System
ClassificationPlate, Fixation, Bone
Applicant Jeil Medical Corporation #702, Kolon Science Valley 2nd 55, Digital-ro 34, Guro-gu Seoul,  KR 152-728
ContactSejin Ryu
CorrespondentSejin Ryu
Jeil Medical Corporation #702, Kolon Science Valley 2nd 55, Digital-ro 34, Guro-gu Seoul,  KR 152-728
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-01
Decision Date2017-07-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806390884785 K170313 000
08800089403790 K170313 000
08800089403806 K170313 000
08800089403813 K170313 000
08800089403820 K170313 000
08806390883474 K170313 000
08806390878449 K170313 000
08806390878456 K170313 000
08806390878463 K170313 000
08806390878470 K170313 000
08806390878487 K170313 000
08806390879118 K170313 000
08806390879125 K170313 000
08800089402113 K170313 000

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