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    K Number
    K020457
    Device Name
    AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE
    Manufacturer
    AXIAMED, INC.
    Date Cleared
    2002-09-26

    (227 days)

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

    AXIAMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the AXIAMED Trans-Sacral Spinal Access Device is for minimally invasive access to the anterior portion of the lower spine for the purpose of assisting in the treatment of decompression of the lumbar disc or the performance of lumbar discectomy.
    Device Description
    The AXIAMED Trans-Sacral Spinal Access Device is for minimally invasive access to the anterior lower spine and consists of the following components: Blunt Trocar with Trocar Guide Stylet Threaded Guide Dilator Sheath, Small Dilator Sheath, Large Threaded Guide Sheath, 3mm Threaded Guide Sheath, 4mm Drill Bit, 3 mm Drill Bit, 4mm Delivery Cannula with blunt stylet
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