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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K254188
Device Name Meniscus Versaflex
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
Date Received12/23/2025
Decision Date 02/19/2026
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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