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510(k) Data Aggregation

    K Number
    K191854
    Device Name
    Premia Spine XL Instruments
    Manufacturer
    Date Cleared
    2019-10-08

    (90 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Premia Spine, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Premia Spine XL Instruments are intended to be used during the preparation and placement of Premia Spine screws during surgery to assist the surgeon in precisely locating anatomical structure in either open or minimally invasive procedures. Premia Spine XL Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. The XL Instruments are nonsterile instruments that can be used manually. These instruments are intended to be used with the Medtronic's StealthStation Navigation System.
    Device Description
    The XL Instruments is comprised of seven instruments: - Cannulated Screwdriver; - Cannulated Pedicle AWL; - Cannulated Pedicle Probe; - Cannulated TAP XL 4.5, 5.5 and 6.5 mm; - Straight Pedicle Probe. The XL Instruments are reusable stereotaxic surgical instruments, designed to be used with the Medtronic StealthStation navigation system. They are reusable (autoclavable) instruments, intended to be used in a sterile environment, and initially supplied non-sterile to the user and requires the user to process (i.e., clean and sterilize) the device for initial use, as well as after each use.
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