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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K230546
Device Name SIGNEX
Applicant
Osteonic Co., Ltd.
1206ho, 38 Digital-Ro 29-Gil
Guro-Gu,  KR 08381
Applicant Contact Hye-Min Ahn
Correspondent
Osteonic Co., Ltd.
#507, #508, 166 Gasan Digital 2-Ro
Geumcheon-Gu,  KR 08507
Correspondent Contact Sanglok Lee
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received02/28/2023
Decision Date 06/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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