Balteum™ Lumbar Plate System

Appliance, Fixation, Spinal Intervertebral Body

Huvexel Co., Ltd

The following data is part of a premarket notification filed by Huvexel Co., Ltd with the FDA for Balteum™ Lumbar Plate System.

Pre-market Notification Details

Device IDK200846
510k NumberK200846
Device Name:Balteum™ Lumbar Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
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 2900 Potshop Lane, Suite 200 Eagleville,  PA  19403
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-31
Decision Date2020-05-05

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