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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K030909
Device Name AAP ACROPLATE
Applicant
Aap Implantate AG
Lorenzweg 5
Berlin,  DE 12099
Applicant Contact DIPL.-LNG. CHRISTIAN ABEL
Correspondent
Aap Implantate AG
Lorenzweg 5
Berlin,  DE 12099
Correspondent Contact DIPL.-LNG. CHRISTIAN ABEL
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/24/2003
Decision Date 04/10/2003
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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