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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 K230141
Device Name LOQTEQ® VA Elbow Plates 2.7/3.5 System
Applicant
aap Implantate AG
Lorenzweg 5
Berlin,  DE 12099
Applicant Contact Agnieszka Mierzejewska
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Melissa Burbage
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/18/2023
Decision Date 03/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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