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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K253749
Device Name Affixus® Natural Nail® Proximal Humeral System
Applicant
Zimmer Switzerland Manufacturing GmbH
Sulzerallee 8
Winterthur,  CH 8404
Applicant Contact Melanie Mitrov
Correspondent
Zimmer Switzerland Manufacturing GmbH
Sulzerallee 8
Winterthur,  CH 8404
Correspondent Contact Melanie Mitrov
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/25/2025
Decision Date 12/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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