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510(k) Data Aggregation

    K Number
    K963030
    Device Name
    LEIBINGER IMF SCREW
    Manufacturer
    HOWMEDICA LEIBINGER, INC.
    Date Cleared
    1997-04-11

    (249 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K820944,K912932,K963740
    Predicate For
    K050478,K050535,K140037,K980760,K983728
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This submission describes a small bone screw intended for use in temporary maxillomandibular fixation to provide indirect stabilization of the maxilla, mandible, or both.

    Device Description

    The Leibinger® IMF Screw is 2.0 mm in diameter and ranges from 10.5-18.5 mm in total length (6-14 mm in threaded length). There is a hole in the screw head through which a wire can be passed to fix the maxilla and mandible. The device is for single use only.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance against such criteria, sample sizes, expert qualifications, or details about ground truth establishment.

    The document is a 510(k) premarket notification letter from the FDA to Howmedica Leibinger, Inc. regarding their Leibinger IMF Screw. It confirms the substantial equivalence of the device to legally marketed predicate devices. It lists the device's proprietary name, common name, classification, and manufacturing details. It also mentions the basis for equivalence (similarities in intended use, material, design, and operational principle to other existing devices).

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

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