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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K073311
FOIA Releasable 510(k) K073311
Device Name OSTEOTRANS-OT PIN
Applicant
Takiron Co., Ltd.
7-1-19, Minatojimaminamimachi,
Chuo-Ku, Kobe, Hyogo,  JP 650-0047
Applicant Contact KUMIHIRO HATA
Correspondent
Takiron Co., Ltd.
7-1-19, Minatojimaminamimachi,
Chuo-Ku, Kobe, Hyogo,  JP 650-0047
Correspondent Contact KUMIHIRO HATA
Regulation Number888.3040
Classification Product Code
HTY  
Date Received11/23/2007
Decision Date 05/13/2008
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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