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510(k) Data Aggregation

    K Number
    K042340
    Device Name
    KASIOS TCP
    Manufacturer
    KASIOS BIOMATERIALS
    Date Cleared
    2004-11-24

    (86 days)

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

    KASIOS BIOMATERIALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Kasios TCP is indicated only for filling bone voids or defects that are not intrinsic to the stability of the bony structure. Kasios TCP is to be gently packed into bony voids or gaps of the skeletal system (such as the extremities, spine and the pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Kasios TCP is a bone graft substitute that resorbs and is replaced with bone during the healing process.
    Device Description
    The KASIOS TCP is a synthetic resorbable calcium phosphate bone void filler. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range of 200 to 500um. The device is available in a variety of shapes and sizes.
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