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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 K233008
Device Name Cannulated Headless Bone Screws
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 Kevin A. Thomas
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTY  
Date Received09/22/2023
Decision Date 06/05/2024
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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