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    K Number
    K130400
    Device Name
    MERETEC CS, CORTICAL SCREWS
    Manufacturer
    MERETE MEDICAL GMBH
    Date Cleared
    2013-04-05

    (45 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MERETEC CS, CORTICAL SCREWS

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

    Merete® CS, Cortical Screws 3.0 and 3.5mm can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, wrists, ankles, fingers and toes.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a medical device (Merete® CS, Cortical Screw 3.0 and 3.5mm) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as described in the prompt.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use, technological characteristics, and performance. However, it does not include a detailed report of a study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot answer the questions based on the provided input.

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