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510(k) Data Aggregation

    K Number
    K254188

    Validate with FDA (Live)

    Device Name
    Meniscus Versaflex
    Manufacturer
    GM Dos Reis Industria e Comercio Ltda.
    Date Cleared
    2026-02-19

    (58 days)

    Product Code
    N/A
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K252664,K203393
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K252664

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Meniscus Versaflex is indicated for repair of the meniscus.

    Device Description

    Meniscus Versaflex - All Inside Meniscal Suture with Bendable Tip is an arthroscopy suture, non-absorbable, assembled in an insertion device. The inserter mechanism can be molded for better access to the posterior areas, medium region and anterior third of meniscus, with use of a bending tool and the options (models) of general use and reverse. Each device has two implants of non-absorbable polymer PEEK, previously connected with a UHMWPE suture and pre-assembled in an insertion system. The inserter is offered in a curved and reverse curved configuration. It is provided in sterile condition sterilized by Ethylene Oxide.

    AI/ML Overview

    N/A

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