Main information

  • Trade name:
  • Nerve-locating system, line-powered
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Nerve-locating system, line-powered
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218608
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


National Surgical Pty Ltd - Nerve-locating system, line-powered

ARTG entry for

Medical Device Included Class IIa


National Surgical Pty Ltd

Postal Address

239 Milton Road,MILTON, QLD, 4064


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.




Innovative Surgical Solutions LLC

21520 Bridge Street

Southfield, MI, 48033

United States Of America


1. Nerve-locating system, line-powered

Product Type

Medical device system

Effective date



46456 Nerve-locating system, line-powered

Intended purpose

The device consists of a control unit, power supply, sensor harness and user manual packaged together

as a system. The device is intended for use in surgical procedures to assist the surgeon in locating and

mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of

nerves. The device is indicated for locating and identifying spinal nerce roots and peripheral motor nerves

originating from spinal nerves C3-T1 and L2-S2.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at

Public Summary

Page 1 of

Produced at 10.11.2017 at 09:54:14 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

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