Summary for ARTG Entry:
Nuvasive (Aust/NZ) Pty Ltd - Spinal 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 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.
7475 Lusk Boulevard
San Diego, CA, 92121
United States Of America
1. Spinal cage
Single Device Product
38161 Spinal cage
Intervertebral Body Fusion
The NuVasive CoRoent System is indicated for intervertebral body fusion of the spine in skeletally mature
patients. The System is designed for use with autogenous bone graft to facilitate fusion.
The CoRoent L and XL platforms are intended for use at either one level or two contiguous levels in the
lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I
spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have
had at least six months of non-operative treatment. The System is intended to be used with supplemental
internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
The CoRoent S platforms are intended for use for anterior cervical interbody fusion in patients with cervical
degenerative disc disease (DDD) at one level from levels C2-C3 to C7- T1. The cervical devices are to be
used in patients who have had at least six weeks of non-operative treatment. The System is intended to be
used with supplemental fixation and autogenous bone graft only to facilitate the fusion.
Partial Vertebral Body Replacement
The NuVasive CoRoent System may also be used as a partial vertebral body replacement device
indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body
caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression
of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal
fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft
material may be used at the surgeon's discretion.
No Specific Conditions included on Record
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