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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 K250197
Device Name Estremo Fibular Nail
Applicant
Citieffe S.R.L.
Via Armaroli 21
Calderara Di Reno,  IT 40012
Applicant Contact Federica Giovetti
Correspondent
Citieffe S.R.L.
Via Armaroli 21
Calderara Di Reno,  IT 40012
Correspondent Contact Federica Giovetti
Regulation Number888.3020
Classification Product Code
HSB  
Date Received01/23/2025
Decision Date 10/17/2025
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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