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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 K150974
Device Name aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium
Applicant
Aap Implantate AG
Lorenzweg 5
Berlin,  DE D-12099
Applicant Contact CHRISTIAN ZIETSCH
Correspondent
Aap Implantate AG
Lorenzweg 5
Berlin,  DE D-12099
Correspondent Contact CHRISTIAN ZIETSCH
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/13/2015
Decision Date 04/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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