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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 K080101
Device Name AAP CANNULATED SCREW AND DARCO HEADED SCREW
Applicant
AAP IMPLANTATE AG
LORENZWEG 5
berlin,  DE 12099
Applicant Contact marc seegers
Correspondent
AAP IMPLANTATE AG
LORENZWEG 5
berlin,  DE 12099
Correspondent Contact marc seegers
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/14/2008
Decision Date 03/25/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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