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510(k) Data Aggregation

    K Number
    K031673
    Device Name
    REFOBACIN -PALACOS G
    Manufacturer
    HERAEUS KULZER GMBH & CO. KG
    Date Cleared
    2004-05-25

    (361 days)

    Product Code
    LOD
    Regulation Number
    888.3027
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    REFOBACIN -PALACOS G

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

    PALACOS G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

    Device Description

    Palacos® G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called PALACOS® G, which is a bone cement. This document describes the device, its intended use, and its equivalence to a predicate device.

    However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. This type of information is typically found in the clinical or performance data sections of a 510(k) submission, which are not present in this summary.

    Therefore, I cannot provide the requested table or detailed study information based on the provided text.

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