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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 K080879
Device Name ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM
Applicant
Bioretec, Ltd.
Hermiakatu 22 Modulight Bldg
Tampere,  FI FI-33720
Applicant Contact MARI RUOTSALAINEN
Correspondent
Bioretec, Ltd.
Hermiakatu 22 Modulight Bldg
Tampere,  FI FI-33720
Correspondent Contact MARI RUOTSALAINEN
Regulation Number888.3040
Classification Product Code
HTY  
Date Received03/31/2008
Decision Date 06/24/2008
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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