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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 K171299
Device Name Fixone Biocomposite Anchor
Applicant
Aju Pharm Co., Ltd.
A-207, 697, Pangyo-Ro
Seongnam-Si,  KR 13511
Applicant Contact Kim Jung Gil
Correspondent
Plusglobal
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number888.3030
Classification Product Code
MAI  
Date Received05/03/2017
Decision Date 08/24/2017
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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