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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 K181540
Device Name Estremo Citieffe Nailing System
Applicant
Citieffe S.R.L.
Via Armaroli 21
Calderara Di Reno,  IT 40012
Applicant Contact Stefano Pullega
Correspondent
Citieffe S.R.L.
Via Armaroli 21
Calderara Di Reno,  IT 40012
Correspondent Contact Stefano Pullega
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/11/2018
Decision Date 01/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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