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510(k) Data Aggregation

    K Number
    K213392
    Device Name
    INLIANT Surgical Navigation System
    Manufacturer
    Navigate Surgical Technologies Inc.
    Date Cleared
    2022-02-22

    (130 days)

    Product Code
    PLV
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Navigate Surgical Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INLIANT Surgical Navigation System (INLIANT) is a computerized navigational system intended to provide assistance in both pre-operative planning and the intra-operative surgical phase of dental implantation procedures. INLIANT provides software to pre-operatively plan dental implantation procedures and provides navigational guidance of surgical instruments. INLIANT is intended for use for partially edentulous adult patients who require dental implants as part of their treatment plan.
    Device Description
    INLIANT is a dynamic surgical navigation system designed to allow a clinician to plan a dental procedure and then provide accurate guidance in real-time as to the location of dental surgical tool's drill tip relative to the patient's anatomy and plant position during the dental surgical procedure. INLIANT includes a stand-alone cart which provides mobility and structural support for the computer, monitor and the camera which consists of two high resolution optical image sensors and lens assemblies. The system also includes the handpiece (model WI-75 LED G cleared under K080939), Patient Trackers and Fiducial Kit. Operation of INLIANT is based on optical tracking. Stereoscopic images of the markers on the Patient Tracker and a handpiece are captured by the camera above the surgical site. INLIANT software processes the captured images to determine the location and orientation of the hand piece with respect to the Patient Tracker which is rigidly attached to the patient. The position of the handpiece, drill and the planned implant position is overlaid on existing CBCT scans of the patient's jaw and displayed to the clinician.
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