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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K233659
Device Name Suture Wing
Applicant
Osteonic Co., Ltd.
1004ho, 38, Digital-Ro, 29-Gil, Guro-Gu
Seoul,  KR 08381
Applicant Contact Da Hee Kim
Correspondent
Wise Company, Inc.
#1107, #1108, 204, Gasan Digital 1-Ro, Geumcheon-Gu
Seoul,  KR 08502
Correspondent Contact Sanglok Lee
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/15/2023
Decision Date 12/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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