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510(k) Data Aggregation

    K Number
    K140913
    Device Name
    NUROS BONE GRAFT SUBSTITUTE
    Date Cleared
    2015-02-17

    (313 days)

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

    ORIENTAL RESOURCES DEVELOPMENT LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NuROs Bone Graft Substitute is an implant intended to fill bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NuROs Bone Graft Substitute resorbs and is replaced with bone during the healing process.
    Device Description
    NuROs Bone Graft Substitute is an osteoconductive bone void filler with interconnective pore system. It is made of synthetic beta-tricalcium phosphate (B-TCP) indicated for bone void filling. It is suitable for individuals with bone voids of gaps, caused by surgery or trauma. NuROs Bone Graft Substitute is available in granule type and block type with different volumes which are 1c.c, 2.5c.c, 5c.c, 10c.c, 20c.c, 25c.c and 30c.c. Granule types are provided in 0.2 ~ 0.5mm, 0.5 ~ 1mm, 1 ~ 2mm and 3mm of particle size. Block type is provided in 5mm x 5mm x 10mm, 5mm x 20mm, 10mm x 10mm x 10mm and 10mm x 25mm x 25mm size. NuROs Bone Graft Substitute is pure ß-TCP with all crystalline phase. The Ca/P ratio is 1.5. The structure of the material is multidirectional interconnective porosity with >70% porosity. The propose device does not impart mechanical strength to surgical site. The NuROs Bone Graft Substitute is gamma irradiated and provided for single use only.
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