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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 K172699
Device Name Agile Nail
Applicant
Orthofix Srl
Via Delle Nazioni 9
Bussolengo,  IT 37012
Applicant Contact Gianluca Ricadona
Correspondent
Wagoner Consulting, LLC
P.O. Box 15729
Wilmington,  NC  24408
Correspondent Contact Cheryl Wagoner
Regulation Number888.3020
Classification Product Code
HSB  
Date Received09/07/2017
Decision Date 04/23/2018
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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