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
239 Milton Road,MILTON, QLD, 4064
ARTG Start Date
Medical Device Class IIa
- 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
Medical device system
46456 Nerve-locating system, line-powered
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.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 09:54:14 AEDT
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