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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 K254253
Device Name LOQTEQ® VA Proximal Humerus Plate 3.5
Applicant
Aap Implantate AG
Lorenzweg 5
Berlin,  DE 12099
Applicant Contact Andreas Reuter
Correspondent
PaxMed International, LLC
1925 Palomar Oaks Way
Suite 210
Carlsbad,  CA  92008
Correspondent Contact Kevin Thomas
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/29/2025
Decision Date 03/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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