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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 K250559
Device Name GMReis Fibula Nail System
Applicant
Gm Dos Reis Industria E Comercio
Avenida Pierre Simon De Laplace, 600
Campinas,  BR 13069320
Applicant Contact Guilherme Esteves Pontes
Correspondent
Gm Dos Reis Industria E Comercio
Avenida Pierre Simon De Laplace, 600
Campinas,  BR 13069320
Correspondent Contact Guilherme Esteves Pontes
Regulation Number888.3020
Classification Product Code
HSB  
Date Received02/25/2025
Decision Date 06/12/2025
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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