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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 K232648
Device Name RODEO Telescopic Nail
Applicant
Orthofix Srl
Via Delle Nazioni
9
Bussolengo,  IT 37012
Applicant Contact Elvira Taccarelli
Correspondent
Orthofix US, LLC
3451 Plano Pkwy.
Lewisville,  TX  75056
Correspondent Contact Mitchell Dhority
Regulation Number888.3020
Classification Product Code
HSB  
Date Received08/31/2023
Decision Date 05/03/2024
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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