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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 K133950
FOIA Releasable 510(k) K133950
Device Name ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)
Applicant
Bioretec, Ltd.
Hermiankatu 22, Moduligth Bldg.
Tampere,  FI FI-33720
Applicant Contact MINNA RASANEN
Correspondent
Bioretec, Ltd.
Hermiankatu 22, Moduligth Bldg.
Tampere,  FI FI-33720
Correspondent Contact MINNA RASANEN
Regulation Number888.3040
Classification Product Code
HTY  
Date Received12/23/2013
Decision Date 01/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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