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510(k) Data Aggregation

    K Number
    K062260
    Device Name
    OSTEOBOOST-BMA
    Manufacturer
    Date Cleared
    2006-10-26

    (83 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Orthos-BMA™ kit is intended for use by suitable trained surgical personnel only. The Orthos-BMA™ kit contains the apparatus required to harvest bone marrow and to combine the harvested marrow cells with an osteoconductive material such as a bone void filler for use in the treatment of osseous defects which can occur as a result of trauma or in skeletal defects created surgically.
    Device Description
    The Orthos-BMA™ kit contains the apparatus required for the collection of bone marrow using a minimally invasive aspiration technique. The Orthos-BMA™ kit provides the surgeon with a convenient method of harvesting autologus bone marrow and combining it with their choice of osteoconductive material such as autogenous bone or a bone void filler such as ßGran synthetic osteoconductive scaffold. The Orthos-BMA kit is supplied sterile for single patient use.
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