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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K260390
Device Name Super Upper Limbs Versalock Plating System
Applicant
GM Dos Reis Industria e Comercio Ltda.
Avenida Pierre Simon De La Pl., 600
Campinas,  BR 13069320
Applicant Contact Guilherme Esteves Pontes
Correspondent
GM Dos Reis Industria e Comercio Ltda.
Avenida Pierre Simon De La Pl., 600
Campinas,  BR 13069320
Correspondent Contact Guilherme Esteves Pontes
Date Received02/06/2026
Decision Date 03/17/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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