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510(k) Data Aggregation

    K Number
    K131304
    Device Name
    SENTIO MMG
    Manufacturer
    INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS")
    Date Cleared
    2014-05-29

    (387 days)

    Product Code
    PDQ, SEN
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS")

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. This device is indicated for locating and identifying spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2.
    Device Description
    The Sentio MMG® system is a multichannel intraoperative monitor for use during surgeries in which a motor nerve is at risk. The Sentio MMG® system records mechanomyographic (MMG) signals from muscles innervated by the affected nerve, which may originate from operator applied electrical stimulus or from direct mechanical stimulus occurring during the course of surgery. The monitor will assist early nerve identification by providing the surgeon with a tool to help locate and identify the particular nerve at risk to minimize trauma by alerting the surgeon when a particular nerve has been activated. The Sentio MMG® system consists of a reusable Control Unit comprised of a touch-screen PC and Patient Module, a reusable Sensor Connector Module and an assortment of disposable conductive probes, stimulators, sensors, electrodes and electrode leads.
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    K Number
    K100992
    Device Name
    NEURALMAS
    Manufacturer
    INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS")
    Date Cleared
    2010-09-24

    (168 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS")

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. This device is indicated for locating and identifying spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2.
    Device Description
    The NeuralMAS™ system is a multichannel intraoperative monitor for use during surgeries in which a motor nerve is at risk. The NeuralMAS™ system records mechanomyographic (MMG) signals from muscles innervated by the affected nerve, which may originate from operator applied electrical stimulus or from direct or indirect mechanical stimulus occurring during the course of surgery. The monitor will assist early nerve identification by providing the surgeon with a tool to help locate and identify the particular nerve at risk to minimize trauma by alerting the surgeon when a particular nerve has been activated. The NeuralMAS™ system consists of a reusable Patient Module, a Control Unit comprised of a touch-screen PC and an assortment of disposable conductive probes, stimulators, sensors, electrodes and electrode leads.
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