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510(k) Data Aggregation

    K Number
    K111001
    Device Name
    STERILE STORM (R) OPERATING KIT
    Date Cleared
    2011-05-17

    (36 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTELLIGENT ORTHOPAEDICS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The STΦRM™ Operating Kit is used in conjunction with the STΦRM™ in the reduction and fixation of fractures of the lower leg or distal femur.
    Device Description
    The STΦRM™ Operating Kit consists of two Kirschner wires with collets (diameter 2mm; one length 280mm, the other length 400mm), two self threading 4.5mm bone screws and a 3.2mm single use drill bit.
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    K Number
    K070724
    Device Name
    IOS EXTERNAL FIXATOR, MODEL 2-0-0
    Date Cleared
    2007-05-16

    (62 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTELLIGENT ORTHOPAEDICS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IQS fixator is intended for use in the treatment of bone conditions including fracture fixation and other bone conditions which are amenable to treatment by the use of external fixation.
    Device Description
    The ids fixator construct comprises of a main body which incorporates a central portion with larger ends with three 10mm diameter holes in each to accommodate bone screws. It is available in two lengths - 70 mm and 110mm. A screw sleeve fits into each hole and the bone screw is passed through each sleeve and into the bone fragment through the skin. The bone screw is secured to the fixator using a grub screw (passing through the sleeve) and tightening onto the screw directly. The ids fixator is a single use device.
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    K Number
    K061607
    Device Name
    STORM OPERATING KIT, MODEL 1-10-0
    Date Cleared
    2006-07-18

    (39 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTELLIGENT ORTHOPAEDICS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The STORM™ Operating Kit is used in conjunction with the STΦRM™ in the reduction and fixation of fractures of the lower leg or distal femur
    Device Description
    The STORM®® Operating Kit consists of two Kirschner wires with collets (diameter 2mm; one length 280mm, the other length 400mm), two self threading 4.5mm bone screws and a 3.2mm single use drill bit.
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