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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, Threaded
510(k) Number K131459
Device Name AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE
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
JDW  
Subsequent Product Code
HTY  
Date Received05/20/2013
Decision Date 10/17/2013
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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