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510(k) Data Aggregation

    K Number
    K153519
    Device Name
    DReal
    Date Cleared
    2016-03-16

    (99 days)

    Product Code
    Regulation Number
    882.4310
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREVATURE MEDICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Carevature DReal™ is intended to be used with high-speed compatible electric and pneumatic motors. When used with these motors, it is intended to cut bone by drilling, reaming, decorticating, shaping, dissecting, shaving and smoothing for neurosurgical and spinal applications. Specific applications include laminectomy/laminotomy and craniotomy/craniectomy/ skull base cuts < 1 cm3.
    Device Description
    The DReal™ is a handheld bone-removal device based on a rotating cutter, with a protective shield (hood) partially covering the cutter; following its indications for use, it is designed to cut bone < 1 cm3. The DReal™ comprises a handpiece with a plastic grip ("handle") and a central shaft that curves at its distal end ("tip"). The curved tip is equipped with an active, drill-like cutter that is protected by an extension of the central shaft as a protective shield. The DReal™ has two models, with different angles of curvature at the distal end: Short 45° and Long 75°. Located in the proximal end of the handle, is the motor adaptor (the motor is not part of the supplied product). The DReal™ principles of operation are the same as any other bone cutting tool, as well as the predicate device; it uses electrical or pneumatic power to rotate a cutting element that is approximated to the bone requiring cutting. The DReal™ has an irrigation port on its handle that connects to irrigation source. Irrigation should be running at all times while the DReal™ is active. In case of irrigation malfunction, irrigation can be added externally as with any high-speed, rotating power device, including the predicate. The DReal™ can be powered by an electric or pneumatic motors using a 'micro' adaptor as per ISO 3964; however, it can rotate only clockwise (right-hand, or Forward).
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