Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Nuvasive (Aust/NZ) Pty Ltd - Metal-polymer composite spinal fusion cage
ARTG entry for
Medical Device Included Class IIb
Nuvasive (Aust/NZ) Pty Ltd
PO Box 422, KEW EAST, VIC, 3102
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
- 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.
7475 Lusk Boulevard
San Diego, CA, 92121
United States Of America
1 . Metal-polymer composite spinal fusion cage
Single Device Product
61230 Metal-polymer composite spinal fusion cage
NuVasive interbody system are indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is
designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to
facilitate fusion and supplemental internalspinal fixation systems for use in the thoracolumbar spine.
The systems are intended for use in interbody fusions in the thoracic spine, from T1 to T12, and at the thoracolumbar junction
(T12-L1). The system implants are also intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc
disease or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation The interbody systems
can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
When used in the cervical spine, the interbody implants are indicated for intervertebral body fusion of the spine in skeletally mature
patients. The cervical interbody systems are intended for use for anterior cervical interbody fusion in patients with cervical disc
degeneration and/or cervical spinal instability, that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels
from C2-T1. The system is intended to be used with or without supplemental fixation. The System is designed for use with
autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion.
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 22.07.2020 at 09:29:52 AEST
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