Australia - English - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 64252 - distraction rod locator - a noninvasive, non-powered device intended to be used to accurately locate the magnet within an implanted spinal distraction rod (nail) so that a distraction rod controller can then be used to adjust the length of the distraction rod. this is a reusable device.

Australia - English - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 45200 - stereotactic surgery system, orthopaedic - a system consisting of cameras, positioning and alignment components, computer, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices to provide real-time navigation information to the surgeon during surgery. the system includes computerized functions to store diagnostic images used for image-guided surgery.

Australia - English - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 40935 - workstation, diagnostic imaging, x-ray system - lessray is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease. lessray is intended for use with a standard c-arm or fluoroscope during a surgical or interventional procedure. when used in connection with the low-dose and/or pulse setting on the fluoroscope, the user may improve the quality (clarity, contrast, noise level, and usability) of a noisy (low-quality) image. by using this system, some or much of the graininess of low-radiation dose images may be eliminated, allowing for greater utility of low-dose imaging in the o.r. lessray works by combining (or in some cases alternating) the current image being taken with a prior ?learned? image of the same anatomy. the initial image, taken at full radiation dose settings, serves as the ?baseline? to which images taken at lower dose radiation settings are compared to and enhanced.

Australia - English - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 34170 - prosthesis, internal, spine, vertebral body - a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine 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 for use in the thoracic and lumbar spine.

Australia - English - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 61533 - interspinous spinal fixation implant - the affix i, ii, and iii system is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine. it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in for degenerative disc disease, spondylolisthesis, trauma and/or tumor. the affix system is not intended for stand-alone use.

Australia - English - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 61324 - bone-screw internal spinal fixation system, sterile - a thoracolumbar and sacral pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of degenerative disc disease. spondylolisthesis, fracture, dislocation, spinal deformities, spinal tumor and/or failed previous fusion (pseudoarthrosis). when used as an anterolateral non-pedicle screw system in the thoracolumbar spine, it is also intended for the same indications listed above. its also indicated for the treatment of severe spondylolisthesis of the l5-s1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft. when used for posterior non-cervical screw fixation in pediatric patients, it is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis, spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma.

Australia - English - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 61325 - bone-screw internal spinal fixation system, non-sterile - a thoracolumbar and sacral pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of degenerative disc disease. spondylolisthesis, fracture, dislocation, spinal deformities, spinal tumor and/or failed previous fusion (pseudoarthrosis). when used as an anterolateral non-pedicle screw system in the thoracolumbar spine, it is also intended for the same indications listed above. its also indicated for the treatment of severe spondylolisthesis of the l5-s1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft. when used for posterior non-cervical screw fixation in pediatric patients, it is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis, spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma.

Australia - English - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 44797 - fixation cable - the versatie system is a temporary implant for use in orthopaedic surgery. the system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. the indications for use include spinal trauma surgery, used in sublaminar or facet wiring techniques, spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis and spinal degenerative surgery, as an adjunct to spinal fusions. the versatie system may also be used in conjunction with other medical implants made of titanium alloy or cobalt chromium alloy whenever ?wiring? may help secure the attachment of the other implants.

Australia - English - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 61465 - internal spinal fixation system cable, non-sterile - the versatie system is a temporary implant for use in orthopaedic surgery. the system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. the indications for use include spinal trauma surgery, used in sublaminar or facet wiring techniques, spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis and spinal degenerative surgery, as an adjunct to spinal fusions. the versatie system may also be used in conjunction with other medical implants made of titanium alloy or cobalt chromium alloy whenever ?wiring? may help secure the attachment of the other implants.

Australia - English - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 48164 - cervical total disc replacement prosthesis - the simplify disc is indicated for use in skeletally mature patients for reconstruction of the disc from c3-c7 following discectomy for cervical degenerative disc disease defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to an abnormality localized to the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging (e.g., x-rays, computed tomography (ct), magnetic resonance imaging (mri)): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes or dark disc), and/or visible loss of disc height as compared to adjacent levels. patients receiving the simplify disc should have failed at least six weeks of non-operative treatment or have the presence of progressive symptoms (e.g. numbness or tingling) or have signs of nerve root compression prior to implantation. the simplify disc is implanted via an open anterior approach.