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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K242596
Device Name Versalock Mini and Micro Plating System
Applicant
GM Dos Reis Industria e Comercio Ltda.
Avenida Pierre Simon De Laplace, 600
Campinas,  BR 13069320
Applicant Contact Guilherme Esteves Pontes
Correspondent
GM Dos Reis Industria e Comercio Ltda.
Avenida Pierre Simon De Laplace, 600
Campinas,  BR 13069320
Correspondent Contact Guilherme Esteves Pontes
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/30/2024
Decision Date 11/21/2024
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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