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510(k) Data Aggregation

    K Number
    K023868
    Device Name
    DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
    Manufacturer
    DANNORITZER MEDICAL INSTRUMENTS
    Date Cleared
    2003-02-07

    (79 days)

    Product Code
    HAE
    Regulation Number
    882.4840
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DAN KERRISON RONGEURS, MODELS K1 + BILLY 1

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

    DANNORITZER manual rongeurs are designed for cutting or biting bone during surgery involving the skull or spinal column.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement. The document is a clearance letter from the FDA for a medical device (Dan Kerrison Rongeurs), stating that it is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and marketing permissions but does not delve into specific performance studies or acceptance criteria.

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