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510(k) Data Aggregation

    K Number
    K170165
    Device Name
    Osteo-P Bone Graft Substitute
    Date Cleared
    2017-12-29

    (344 days)

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

    Molecular Matrix, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Osteo-PIM Bone Graft Substitute is indicated for use only in the treatment of bony voids or gaps that are not intrinsic to the stability of the bony structure. It is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis), and the opening to the defect site sealed with bone wax. These defects may be surgically created osseous defects or osseous defects created from traumatic or degenerative injury to the bone. Subsequent to implantation, Osteo-PTM Bone Graft Substitute is resorbed and replaced with bone during the healing process.
    Device Description
    Osteo-PTM Bone Graft Substitute is a radiolucent bone void filler composed of a porous, osteoconductive polymeric carbohydrate with a trabecular structure simulating the multidimensional interconnectivity of human cancellous bone. When placed in direct contact with host bone, Osteo-PTM supports and guides the ingrowth of new bone across the graft site and is resorbed as the healing process occurs. The consistency of Osteo-P™ allows the surgeon to easily manipulate and maximize the direct contact with viable host bone. It is intended for single patient use only and is provided sterile in single-use double sterile packaging. Osteo-P™ is available in various forms to include granules, sheets, cubes, wedges, and cylinders.
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