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510(k) Data Aggregation

    K Number
    K103231
    Device Name
    KYPHON INFLATION SYRINGE
    Date Cleared
    2011-01-24

    (84 days)

    Product Code
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC SPINE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kyphon® Inflation Syringe is intended to be used to inflate and deflate inflatable devices (including Inflatable Bone Tamps) and to measure the pressure within the inflatable device during the procedure.
    Device Description
    The Kyphon® Inflation Syringe consists of a syringe barrel; a threaded plunger assembly with a depress-release handle; a digital display that provides pressure readout; an outer shell assembly that retains the internal components; a flexible tubing designed to withstand high inflation pressures; and a weighted swivel-luer for connection to the inflatable device (including Inflatable Bone Tamps). The device is designed to generate and monitor pressures up to 700psi (providing the user the option to be able to select the Maximum Inflation Pressure of 400psi or 700psi depending on the inflatable device being used). The Locking Syringe (to be packaged together with the Inflation Syringe) is a 30ml polycarbonate syringe and is included for preparation of the inflatable device, as necessary. A V-Klip™ (available as part of the 2 Pack configuration) holds two Kyphon Inflation Syringes for concurrent dual-syringe operation.
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    K Number
    K101765
    Device Name
    KYPHON ANCHOR FACET SCREW SYSTEM
    Date Cleared
    2010-10-22

    (121 days)

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

    MEDTRONIC SPINE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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