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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, Biodegradable, Soft Tissue
510(k) Number K202806
Device Name Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
Applicant
Osteonic Co., Ltd.
39 Digital-Ro 29-Gil
Guro-Gu,  KR 08381
Applicant Contact Da Kyung Ham
Correspondent
Wise Company, Inc.
#303, 142, Gasan Digital-Ro
Geumcheon-Gu,  KR 08507
Correspondent Contact Sanglok Lee
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
MBI  
Date Received09/23/2020
Decision Date 06/17/2021
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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