Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Spinal fixation plate, non-biodegradable
ARTG entry for
Medical Device Included Class IIb
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
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.
Signus Medizintechnik GmbH
Alzenau, , D-63755
1. Spinal fixation plate, non-biodegradable
Medical device system
46653 Spinal fixation plate, non-biodegradable
The plate and screw systems serve to temporarily stabilise the spine until solid bony fusion is complete.
They are not suitable for replacing body structures nor for permanently absorbing forces arising in cases
where fusion has not taken place. Application is via anterior access in patients with instabilities that may
be due to the following reasons: Degenerative disc disease, Spinal canal stenosis, Spondylolisthesis,
Trauma, Tumour and inflammation without bone involvement at the site of fixation, Deformity,
Pseudoarthrosis, and Absence of fusion.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 05:03:11 AEDT
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