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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement
510(k) Number K123225
Device Name BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60
Applicant
Aap Biomaterials GmbH & Co. KG
Lagerstrasse 11-15
Dieburg,  DE 64807
Applicant Contact VOLKER STIRNAL
Correspondent
Aap Biomaterials GmbH & Co. KG
Lagerstrasse 11-15
Dieburg,  DE 64807
Correspondent Contact VOLKER STIRNAL
Regulation Number888.3027
Classification Product Code
LOD  
Date Received10/15/2012
Decision Date 03/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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