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510(k) Data Aggregation

    K Number
    K081284
    Device Name
    VARIAX DISTAL FIBULA PLATE
    Manufacturer
    HOWMEDICA OSTEONICS CORP.
    Date Cleared
    2008-07-18

    (73 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VARIAX DISTAL FIBULA PLATE

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

    The VariAx™ Distal Lateral Fibula Plate is intended for use in internal fixation of the distal fibula.

    Device Description

    This submission is a line extension to the Stryker® Plating System. The components of the VariAx™ Distal Fibula Plate are intended to add a different type of plate to the Stryker® Plating System portfolio.

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (VariAx™ Distal Fibula Plate), not a study report for an AI/ML powered device. As such, the information requested in the prompt (acceptance criteria, details of a study with sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or available in this document.

    The document mainly focuses on establishing substantial equivalence to previously marketed devices based on intended use, design, materials, and operational principles, rather than performance metrics from a clinical study using specific acceptance criteria.

    Therefore, I cannot provide the requested table and study details.

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