AEON-C Stand Alone System

Intervertebral Fusion Device With Integrated Fixation, Cervical

Huvexel Co., Ltd

The following data is part of a premarket notification filed by Huvexel Co., Ltd with the FDA for Aeon-c Stand Alone System.

Pre-market Notification Details

Device IDK191477
501k NumberK191477
Device Name:AEON-C Stand Alone System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant Huvexel Co., Ltd 101-105 Megacenter, SKn Technopark, 124, Sagimakgol-ro, Jungwon-gu Seongnam-si,  KR 13207
ContactSung Kyu Hur
CorrespondentMilan George
Dio Medical Corporation 2000 Campus Lane, Suite 200 Eagleville,  PA  19403
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-04
Decision Date2019-11-13

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