ARIX Small Fragment 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 Small Fragment System.

Pre-market Notification Details

Device IDK221920
510k NumberK221920
Device Name:ARIX Small Fragment 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
ContactBora Kim
CorrespondentBora Kim
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-01
Decision Date2022-08-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800089404186 K221920 000
08800089404049 K221920 000
08800089404087 K221920 000
08800089404094 K221920 000
08800089404100 K221920 000
08800089404117 K221920 000
08800089404124 K221920 000
08800089404131 K221920 000
08800089404148 K221920 000
08800089404155 K221920 000
08800089404162 K221920 000
08800089404179 K221920 000
08800089404032 K221920 000

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