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510(k) Data Aggregation

    K Number
    K061246
    Date Cleared
    2006-08-23

    (112 days)

    Product Code
    Regulation Number
    888.1100
    Reference & Predicate Devices
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arthro Kinetics' Endoscopic Spine System (Kinetics Interchangeable Spine System) is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy.

    Device Description

    The Arthro Kinetics Endoscopic Spine System consists of an Endoscope, light source, light guide, sheaths, camera head, and camera control unit and is a reusable minimally invasive system that enables surgeons to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy. The outer sheath acts to facilitate suction / irrigation to the surgical site, serving as a cannula to provide an access portal for the endoscope to be inserted into the patient for viewing or the placing of manual surgical instruments. By inserting the endoscope into the outer sheath the surgeon will be able to view the operative site whilst being guided to the pain source by the ongoing feedback from the patient. The endoscope also has a working channel to allow surgical instruments to be inserted into the operative site.

    AI/ML Overview

    This is not an AI/ML medical device. This document describes an "Arthro Kinetics Endoscopic Spine System," which is a physical medical device. The information provided in the prompt is for AI/ML medical devices. Therefore, I cannot extract the requested information.

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