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510(k) Data Aggregation

    K Number
    K181262
    Device Name
    SpineJack Expansion Kit
    Manufacturer
    Vexim SA
    Date Cleared
    2018-08-30

    (111 days)

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

    Vexim SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spinelack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. It is intended to be used in combination with Stryker Vertaplex HV bone cements.
    Device Description
    The SpineJack Expansion Kit (herein referred to as "SpineJack") is an implanted fracture reduction system, intended to reduce vertebral compression fractures. The SpineJack Expansion Kit is used with the Preparation Kit. The Expansion Kit is available in three sizes, to accommodate different vertebral body sizes, Ø4.2mm, Ø5mm, and Ø5.8mm. After the SpineJack implant is inserted, it is expanded, and PMMA bone cement is injected at a low pressure to stabilize the restored vertebral body. The bone cement and its delivery system are intended to be used with the SpineJack, but are sold separately.
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