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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K130590
Device Name AAP CANNULATED SCREW 2.0
Applicant
Aap Implantate AG
Lorenzweg 5
Berlin,  DE 12099
Applicant Contact CHRISTIAN ZIETSCH
Correspondent
Aap Implantate AG
Lorenzweg 5
Berlin,  DE 12099
Correspondent Contact CHRISTIAN ZIETSCH
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received03/07/2013
Decision Date 04/22/2013
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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