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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 K260146
Device Name FITBONE® TRANSPORT AND LENGTHENING SYSTEM
Applicant
Orthofix Srl
Via Delle Nazioni, 9
Bussolengo (Vr),  IT 37012
Applicant Contact Elvira Taccarelli
Correspondent
Orthofix Srl
Via Delle Nazioni, 9
Bussolengo (Vr),  IT 37012
Correspondent Contact Chiara Zuliani
Regulation Number888.3020
Classification Product Code
HSB  
Date Received01/20/2026
Decision Date 05/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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