Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Bone-screw internal spinal fixation system, non-sterile
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.
777 Oakmont Lane
Westmont, IL, 60559
United States Of America
1. Bone-screw internal spinal fixation system, non-sterile
Medical device system
61325 Bone-screw internal spinal fixation system, non-sterile
The system consists of longitudinal rods, pedicle screws, cannulated pedicle screws, hooks, lateral
connectors and transverse connectors. The system is intended to provide immobilization and stabilization
of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following
acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe
spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective
evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed
previous fusion (pseudo-arthrosis). The system is also indicated for pedicle screw fixation for the treatment
of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving
fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of
pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after fusion is
attained. The system is also a hook and sacral/iliac screw fixation system of the non-cervical spine
indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc
confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation),
spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion. The
system is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease
(defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic
studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis,
kyphosis, and/or lordosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature
patients. Levels of fixation are for the thoracic, lumbar and sacral spine.
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 02.12.2017 at 05:06:56 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information