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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 K230892
Device Name Fixone Biocomposite Anchor
Applicant
Aju Pharm Co., Ltd.
A-207, 697, Pangyo-Ro
Seongnam-Si,  KR 13511
Applicant Contact Kwon Mingyeong
Correspondent
Plusglobal
300, Atwood St.
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number888.3030
Classification Product Code
MAI  
Date Received03/31/2023
Decision Date 06/09/2023
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
Recalls CDRH Recalls
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