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

nuvasive (aust/nz) pty ltd - 64192 - internal spinal fixation procedure kit, reusable - a collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. this is a reusable device.

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

nuvasive (aust/nz) pty ltd - 60741 - spinal rod bending system - nuvasive sterile, non-invasive, single-use instruments are indicated for use during spinal and image-guided surgical procedures requiring rod bending. when used with the nuvasive pulse bendini spinal rod bending function, digitizer arrays are used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod.

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

nuvasive (aust/nz) pty ltd - 45200 - stereotactic surgery system, orthopaedic - nuvasive sterile, non-invasive, single-use instruments are indicated for use during spinal and image-guided surgical procedures. when used with nuvasive pulse navigation for stereotactic surgery, patient reference arrays provide reference to a rigid anatomical structure which can be identified relative to the acquired image of the anatomy.

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

nuvasive (aust/nz) pty ltd - 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 i

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

nuvasive (aust/nz) pty ltd - 57805 - spinal fusion cage, non-sterile - 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 i

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

nuvasive (aust/nz) pty ltd - 60847 - polymeric spinal fusion cage, sterile - 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 i

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

nuvasive (aust/nz) pty ltd - 60762 - polymeric spinal fusion cage, non-sterile - 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 in

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

nuvasive (aust/nz) pty ltd - 45200 - stereotactic surgery system, orthopaedic - nuvasive surgical instruments are manually operated, non-patient contacting devices for use during spinal surgical procedures. these devices typically include positioning and alignment components and other instruments that may be used for spinal and image-guided surgery.

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

nuvasive (aust/nz) pty ltd - 43257 - fixation system, internal, spinal, bone screw - the nuvasive systems are intended to provide immobilisation and stabilisation 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 posterior thoracic, lumbar, and sacral spine: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and/or failed previous fusion (pseudoarthrosis). the nuvasive systems are also indicated for the treatment of severe spondylolisthesis (grades 3 and 4) of the l5-s1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (l3 to sacrum), with removal of the implants after attainment of a solid fusion.

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

nuvasive (aust/nz) pty ltd - 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 devic