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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 K113602
Device Name AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
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 Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/05/2011
Decision Date 10/31/2012
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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