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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 K243469
Device Name SIGNEX
Applicant
Osteonic Co., Ltd.
405ho, 505-2ho, 505-3ho, 508ho, 902ho, 1004ho, 1201ho,
1202ho, 1206ho 38 Digital-Ro 29-Gil, Guro-Gu
Seoul,  KR 08381
Applicant Contact Hye-Min Ahn
Correspondent
Wise Company, Inc.
#1108, 204 Gasan Digital 1-Ro, Geumcheon-Gu
Seoul,  KR 08502
Correspondent Contact Sanglok Lee
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received11/08/2024
Decision Date 05/29/2025
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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