Australia - English - Department of Health (Therapeutic Goods Administration)
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.
600 Hope Parkway SE
Leesburg, Virginia, 20175
United States Of America
1. Prosthesis, internal, spine, vertebral body
Single Device Product
34170 Prosthesis, internal, spine, vertebral body
The corpectomy cage is a vertebral body replacement device intended for use in the thoracolumbar spine
to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e. fracture). The
corpectomy cage is designed to provide anterior spinal column support even in the absence of fusion for a
prolonged period. The device may be used with allograft or autograft. For all the above indications the
implants are intended to be used with supplemental internal fixation appropriate for the implanted level,
including pedicle screw and hook systems, and spinal plate systems.
No Specific Conditions included on Record
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Produced at 01.12.2017 at 11:29:48 AEDT
This is not an ARTG Certificate document.
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