Summary for ARTG Entry:
Prism Surgical Designs Pty Ltd - Fixation device, internal, spine, construct
ARTG entry for
Medical Device Included Class IIb
Prism Surgical Designs Pty Ltd
PO Box 27,RED HILL, QLD, 4059
ARTG Start Date
Medical Device Class IIb
- 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.
Signature Orthopaedics Europe Ltd
14 Herbert Street Dublin 2
1. Fixation device, internal, spine, construct
Single Device Product
37272 Fixation device, internal, spine, construct
A spinal fixation system that consists of various components such as rods/hooks/screws/connectors and
wires that are used collectively to stabilize, support and/or correct alignment of the spine. The combination
of these components is intended for the treatment of various spinal instabilities, pathologies and/or
deformities. These components may be made of stainless steel, titanium, cobalt chrome or other materials.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 03:33:25 AEDT
This is not an ARTG Certificate document.
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