Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Sacroiliac joint arthrodesis implant
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. Sacroiliac joint arthrodesis implant
Medical device system
58733 Sacroiliac joint arthrodesis implant
A sacroiliac fusion implant for stabilisation of the sacroiliac joint. This implantation is performed through a
posterior approach. The device is indicated for painful sacroiliac joints in skeletally mature patients,
requiring surgical stabilisation by bone grafting and internal fixation.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 05:02:23 AEDT
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