Balex Bone Expander System


Taeyeon Medical Co., Ltd.

The following data is part of a premarket notification filed by Taeyeon Medical Co., Ltd. with the FDA for Balex Bone Expander System.

Pre-market Notification Details

Device IDK202027
510k NumberK202027
Device Name:Balex Bone Expander System
Applicant Taeyeon Medical Co., Ltd. 132-1 Donghwagongdan-Ro, Munmak-eup Wonju-si,  KR 26365
ContactSin-ae Kang
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine,  CA  92620
Product CodeHRX  
Subsequent Product CodeHXG
Subsequent Product CodeNDN
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-22
Decision Date2021-02-03

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