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    K Number
    K992683
    Device Name
    MODUS 2.5 MANDIBULAR TRAUMA SET
    Manufacturer
    MEDARTIS AG
    Date Cleared
    1999-11-24

    (106 days)

    Product Code
    JEY,JFY
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K946165,K950045,K961421
    Why did this record match?
    Device Name :

    MODUS 2.5 MANDIBULAR TRAUMA SET

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

    The MODUS® 2.5 Trauma Set is intended for use in mandibular trauma fractures, e.g. in unstable, comminuted mandibular fractures and bone loss.

    Device Description

    The MODUS® 2.5 Mandibular Trauma Set is a complete fracture fixation system that includes titanium plates, titanium screws, templates, and accompanying instruments and accessories.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device.

    The document is a 510(k) summary for the MODUS® 2.5 Mandibular Trauma Set, which is a premarket notification to the FDA for a medical device. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than detailed performance studies against specific acceptance criteria.

    Therefore, I cannot fulfill your request to create the table and answer the questions based on the given input.

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