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510(k) Data Aggregation

    K Number
    K073214
    Device Name
    DUOWEDGE SYNTHETIC BONE SUBSTITUTE
    Manufacturer
    Date Cleared
    2009-12-01

    (748 days)

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

    KASIOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    When used with appropriate opening osteotomy system devices, plates and screws, Duowedge is intended to be used as a bone void filler in tibial osteotomies. Duowedge is to be used in combination with adequate post-operative immobilization.
    Device Description
    The calcium phosphate ceramic Duowedge manufactured by KASIOS is designed to be used as a bone void filler tibial osteotomies. Duowedge is a synthetic bone substitute. It is a macroporous bioceramic, made of hydroxyapatite and beta tricalcium prosphate. When . it is nony site, Duowedge gradually and partially resorbs and is replaced with bone during the healing process. In addition, Duowedge is intended to be used with appropriate opening osteotomy system devices, plates and screws. Duowedge is for use in combination with adequated postoperative immobilization.
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    K Number
    K042340
    Device Name
    KASIOS TCP
    Date Cleared
    2004-11-24

    (86 days)

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

    KASIOS BIOMATERIALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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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