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510(k) Data Aggregation

    K Number
    K090091
    Device Name
    OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
    Date Cleared
    2009-02-01

    (18 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYLAD ORTHOPEDIC SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OlecraNail™ Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.
    Device Description
    The OlecraNail™ intramedullary rod is a solid bore, stainless steel, tapered rod that is inserted into a pre-drilled hole into the medullary canal of the proximal ulna. Once the device is in place, a carbon fiber composite guide is used to drill into the bone and insert several screws through the bone and rod to secure all bone fragments and lock the rod into position. During this process, compression at the fracture site may be obtained by manually turning a knob to activate the compression mechanism. After all screws are placed, the guide may then be detached using a break-away mechanism.
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    K Number
    K081356
    Device Name
    OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
    Date Cleared
    2008-07-09

    (56 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYLAD ORTHOPEDIC SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OlecraNail™ Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.
    Device Description
    The OlecraNail™ intramedullary rod is a solid bore, stainless steel, tapered rod that is inserted into a pre-drilled hole into the medullary canal of the proximal ulna. Once the device is in place, a combination stainless steel/polyphenylsulfone guide is used to drill into the bone and insert several screws through the bone and rod to secure all bone fragments and lock the rod into position. During this process, compression at the fracture site may be obtained by manually turning a knob to activate the compression mechanism. After all screws are placed, the guide may then be detached using a break-away mechanism.
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