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510(k) Data Aggregation
K Number
K131304Device Name
SENTIO MMG
Manufacturer
INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS")
Date Cleared
2014-05-29
(387 days)
Product Code
PDQ, SEN
Regulation Number
874.1820Why 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
K100992Device Name
NEURALMAS
Manufacturer
INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS")
Date Cleared
2010-09-24
(168 days)
Product Code
ETN
Regulation Number
874.1820Why 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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