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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 K161703
Device Name LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
Applicant
Aap Implantate AG
Lorenzweg 5
Berlin,  DE 12099
Applicant Contact RENI SCHALLER
Correspondent
Aap Implantate AG
Lorenzweg 5
Berlin,  DE 12099
Correspondent Contact RENI SCHALLER
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received06/20/2016
Decision Date 11/04/2016
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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