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510(k) Data Aggregation

    K Number
    K962774
    Device Name
    OSTEOMED QUICKFIX
    Manufacturer
    OSTEOMED CORP.
    Date Cleared
    1997-10-10

    (451 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K151195
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Temporary ligature and wire lock fixation for temporary constriction and stabilization of fractured bone segments in the oral cavity in conjunction with primary fixation devices.

    Device Description

    Smooth or threaded metallic bone fixation fastener; Intraoral ligature and wire lock. Bone screws and associated instruments (Drill bits, screwdrivers,etc.) in conjunction with ligature wire and associated instruments (wire twisters, cutters, etc.)

    AI/ML Overview

    This section is not applicable, as it is a 510(k) premarket notification for a medical device (bone fixation fastener, ligature, and wire lock) and does not involve AI/ML device performance studies. The document describes the FDA's clearance of the device for market based on substantial equivalence, rather than detailing a study against acceptance criteria.

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