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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,  KR 13511
Applicant Contact Kwon Mingyeong
Correspondent
Plus Global
300, Atwood street
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
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