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510(k) Data Aggregation

    K Number
    K202184
    Device Name
    Practical Navigation Surgical Guidance System (PNSGS)
    Manufacturer
    Practical Navigation, LLC
    Date Cleared
    2021-02-24

    (204 days)

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

    Practical Navigation, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Practical Navigation Surgical Guidance System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or Guide Tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in rigid patient anatomy and fiducials that can be identified on an O-arm scan. The Practical Navigation Surgical Guidance System is indicated for assisting the surgeon in placing pedicle in the posterior lumbar region (1-S1). The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Integrity LineSider Pedicle Spinal System.
    Device Description
    The Practical Navigation Surgical Guidance System (PNSGS) is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a Camera, and various image guided instruments intended for assisting the surgeon in placing screws in the pedicles of the lumbar spine. The PNSGS system allows for registration of the patient's anatomy to O-arm images. Once the patient anatomy is registered, a surgical plan can be created and optically-tracked surgical instruments can be used to follow the surgical plan.
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