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510(k) Data Aggregation

    K Number
    K120141
    Device Name
    KENSEY NASH BONE VOID FILLER XC
    Date Cleared
    2012-05-04

    (107 days)

    Product Code
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    KENSEY NASH CORORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kensey Nash Bone Void Filler XC is intended to be gently packed into the bony voids or gaps of the extremities and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. These defects may be created from traumatic injury to the bone or surgically created osseous defects. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood or bone marrow aspirate. The addition of the autogenous products does not alter the performance of the device.
    Device Description
    The Kensey Nash Bone Void Filler XC is a mixture of beta tricalcium phosphate and polylactic acid. The product will be provided gamma sterilized for one time use in a healthcare facility. The products are supplied in a variety of shapes ranging from pre-formed cylinders, granules, cubes, blocks, and wedges ranging up to 25mm in diameter and up to 30cc in volume.
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