ARIX Ankle Fibula Hook Plate 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 Fibula Hook Plate System.

Pre-market Notification Details

Device IDK170979
510k NumberK170979
Device Name:ARIX Ankle Fibula Hook Plate 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 #702,703,704,705,706,804,805,807,812-ho,55 Digital-ro34-gil, Guro-gu, Seoul 152-728 KR
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-03
Decision Date2017-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806390898003 K170979 000
08806390897990 K170979 000

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