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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 K250622
Device Name Succession™ AFN System
Applicant
Ortho Solutions UK , Ltd.
West Station Business Park, Spital Rd., Unit 5
Maldon,  GB CM9 6FF
Applicant Contact Alex Faley
Correspondent
Ortho Solutions UK , Ltd.
West Station Business Park, Spital Rd., Unit 5
Maldon,  GB CM9 6FF
Correspondent Contact Alex Faley
Regulation Number888.3020
Classification Product Code
HSB  
Date Received02/28/2025
Decision Date 08/07/2025
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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