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510(k) Data Aggregation

    K Number
    K050535
    Device Name
    STRYKER MMF SCREW
    Manufacturer
    STRYKER INSTRUMENTS
    Date Cleared
    2005-03-17

    (15 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K963030
    Why did this record match?
    Device Name :

    STRYKER MMF SCREW

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

    The Stryker® MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth.

    The document is a 510(k) summary for a medical device (Stryker® MMF Screw) establishing substantial equivalence to a predicate device. It defines the intended use and regulatory classification but does not include any performance study details or acceptance criteria.

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