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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
Plus Global
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
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