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510(k) Data Aggregation

    K Number
    K091234
    Device Name
    SKELTEX ISV
    Manufacturer
    SKELTEX TECHNOLOGIES, INC.
    Date Cleared
    2010-02-16

    (295 days)

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

    SKELTEX TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Skeltex ISV is intended for percutaneous delivery of PMMA bone cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
    Device Description
    Not Found
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