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510(k) Data Aggregation

    K Number
    K133372
    Device Name
    CROSSTREES PVA POD
    Date Cleared
    2013-12-06

    (35 days)

    Product Code
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    CROSSTREES MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Crosstrees® Pod device is intended to provide surgeons with a percutaneous means to deliver bone cement to painful pathologic compression fractures of the vertebral body in levels T4-L5 of the thoracic and lumbar spine. Pathologic fractures of the vertebral body may be caused by osteoporosis. It is intended to be used in combination with Crosstrees Fortibrae® Bone Cement when delivered by the Crosstrees CDrive® Bone Filler Delivery System.
    Device Description
    The Crosstrees® PVA Pod device is designed to deliver bone cement to the fractured vertebral body in a controlled manner without the need for an additional permanent implant other than the bone cement. The device consists of a shaft assembly for delivery of PMMA cement to a fabric barrier. Following cement delivery, the fabric barrier is opened and withdrawn from the vertebral body. The Crosstrees® PVA Pod device is made from a variety of materials commonly used in orthopedic and radiological procedures including stainless steel and polymers. The device is available in either a 2.0 mL or 3.0 mL fill capacity. The device is provided with a number of class I tools that are used for surgical access and delivery of the Pod to the surgical site, as well as preparation and delivery of bone cement.
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    K Number
    K130089
    Device Name
    CROSSTREES PVA POD
    Date Cleared
    2013-08-09

    (207 days)

    Product Code
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    CROSSTREES MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Crosstrees® PVA Pod device is intended to provide surgeons with a percutaneous means to deliver bone cement to painful pathologic compression fractures of the vertebral body in levels T4-L5 of the thoracic and lumbar spine. Pathologic fractures of the vertebral body may be caused by osteoporosis. It is intended to be used in combination with Crosstrees Fortibrae® Bone Cement when delivered by the Crosstrees CDrive® Bone Filler Delivery System.
    Device Description
    The Crosstrees® PVA Pod device is designed to deliver bone cement to the fractured vertebral body in a controlled manner without the need for an additional permanent implant other than the bone cement. The device consists of a shaft assembly for delivery of PMMA cement to a fabric barrier. Following cement delivery, the fabric barrier is opened and withdrawn from the vertebral body. The Crosstrees® PVA Pod device is made from a variety of materials commonly used in orthopedic and radiological procedures including stainless steel and polymers. The device is available in either a 2.0 mL or 3.0 mL fill capacity. The device is provided with a number of class I tools that are used for surgical access and delivery of the Pod to the surgical site, as well as preparation and delivery of bone cement.
    Ask a Question

    Ask a specific question about this device

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