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510(k) Data Aggregation

    K Number
    K053228
    Device Name
    THERIGRAFT TCP PUTTY BONE VOID FILLER
    Manufacturer
    THERICS, LLC
    Date Cleared
    2006-01-31

    (74 days)

    Product Code
    MQV
    Regulation Number
    888.3045
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    Applicant Name (Manufacturer) :

    THERICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TheriGraft™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and is intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriGraft™ putty creates a network within the defect site that resorbs during healing and is replaced by bone.
    Device Description
    The TheriGraft™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate granules (0.1 - 0.4 mm diameter) in a poloxamer based carrier.
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