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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 K253566
Device Name Affixus Retrograde Femoral Nailing System
Applicant
Zimmer, Inc.
1800 W Center St.
Warsaw,  IN  46835
Applicant Contact Akash Savalia
Correspondent
Zimmer, Inc.
1800 W Center St.
Warsaw,  IN  46835
Correspondent Contact Akash Savalia
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/17/2025
Decision Date 03/12/2026
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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