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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 K202883
Device Name Sterile bone screw (PEEK ACL screw)
Applicant
Osteonic Co., Ltd.
38 Digital-Ro 29-Gil
Guro-Gu,  KR 08381
Applicant Contact Sungmoo Hwang
Correspondent
Wise Company, Inc.
#507-508, 166 Gasan Digital 2-Ro
Geumcheon-Gu,  KR 08503
Correspondent Contact Sanglok Lee
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/28/2020
Decision Date 11/25/2020
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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