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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K253027
Device Name Anchor with Fiber Wire and Disposable Inserter
Applicant
Ortobio S.A.
Avenida Mauá, Nº1133 – Zona 03
Maringá,  BR 87050020
Applicant Contact Arthur Murakami
Correspondent
Pr Serviços Regulatórios Administrativos Ltda
Edifício Pórtico Sul - R. José Jaime Delibo, 160,
Nova Aliança
Ribeirão Preto,  BR 14026-563
Correspondent Contact Tatiana Jabor Botura
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/19/2025
Decision Date 05/06/2026
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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