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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 K202589
Device Name APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System
Applicant
Medartis AG
Hochbergerstrasse 60E
basel,  CH ch-4057
Applicant Contact andrea kiefer-schweizer
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact lauren m. wessell
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
HTN   HTY  
Date Received09/08/2020
Decision Date 11/06/2020
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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