Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Prosthesis, internal, spine, vertebral body
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. Prosthesis, internal, spine, vertebral body
Medical device system
34170 Prosthesis, internal, spine, vertebral body
The vertebral body replacement implant is intended for use for stabilization and reconstruction in complete
or incomplete corpectomy due to destructive damage of the vertebral body, such as can be caused for
instance by tumors, fractures or inflammations in defined regions of the spine.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 05:02:55 AEDT
This is not an ARTG Certificate document.
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