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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K193497
Device Name Fixone Biocomposite Interference Screw
Applicant
Aju Pharm Co., Ltd.
A-207, 697, Pangyo-Ro
Seongnam-Si,  KR 13511
Applicant Contact Kim Joong Kil
Correspondent
Plusglobal
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/17/2019
Decision Date 01/05/2021
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
Recalls CDRH Recalls
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