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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    **HERAEUS KULZER GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K030902
    Device Name
    PALACOS R
    Manufacturer
    HERAEUS KULZER GMBH & CO. KG
    Date Cleared
    2003-09-23

    (183 days)

    Product Code
    LOD
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    **HERAEUS KULZER GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Palacos® R is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
    Device Description
    Palacos® R 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.
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    K Number
    K030903
    Device Name
    OSTEOPAL
    Manufacturer
    HERAEUS KULZER GMBH & CO. KG
    Date Cleared
    2003-09-23

    (183 days)

    Product Code
    LOD
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    **HERAEUS KULZER GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Osteopal® is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixatio of polymer or metallic prosthetic implants to living bone.
    Device Description
    Osteopal® 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.
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    K Number
    K022251
    Device Name
    PALABOND
    Manufacturer
    HERAEUS KULZER GMBH & CO. KG
    Date Cleared
    2003-02-26

    (229 days)

    Product Code
    LOD
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    **HERAEUS KULZER GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PALABOND is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
    Device Description
    Palabond® 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.
    Ask a Question

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