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510(k) Data Aggregation

    K Number
    K023314
    Device Name
    MICROFIX
    Manufacturer
    FIXANO SA
    Date Cleared
    2002-10-18

    (45 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K964094
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Fixano MICROFIX device is intended for use in the external fixation of fractures and/or reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.

    Device Description

    The device is a radiolucent external fixator.

    AI/ML Overview

    This document is a 510(k) summary for the Microfix external fixator and does not contain acceptance criteria or a study proving that acceptance criteria have been met. It is a regulatory submission for premarket notification to the FDA, asserting substantial equivalence to predicate devices, rather than a performance study. No information on device performance, sample size, ground truth establishment, or clinical study details is provided.

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