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

aa-med pty ltd - 61533 - interspinous spinal fixation implant - the spinal simplicity minuteman implants are posterior, non-pedicle supplemental fixation devices, intended for use at a single level in the non-cervical spine (t1-s1). it is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: ? degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); ? spondylolisthesis; ? trauma (i.e., fracture or dislocation); and/or ? tumor. the minuteman implants are intended for use with bone graft material and is not intended for standalone use. the minuteman implants may be implanted via a minimally invasive posterior approach (t1-s1) or a minimally invasive lateral approach (l1- s1)*. *note: the minuteman g3-r implant may not be inserted using a posterior approach.

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

precision surgical pty ltd - 46653 - spinal fixation plate, non-biodegradable - to provide stabilization of the anterior cervical spine (c2 to t1) as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, spinal stenosis, deformity (i.e. kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

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

emergo asia pacific pty ltd t/a emergo australia - 38161 - spinal cage - the system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one or two contiguous level(s) from l2-s1. ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. these ddd patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). this device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. accelfix lumbar expandable cage system is to be used with supplemental fixation. patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

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

emergo asia pacific pty ltd t/a emergo australia - 61324 - bone-screw internal spinal fixation system, sterile - the posterior cervical fixation system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (c1 to c7) and the thoracic spine (t1-t3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. the posterior cervical fixation system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. lnk posterior cervical fixation system and castleloc-s posterior cervical fixation system can be linked to the lnk spinal fixation system via rod to rod connector and transitional rod.

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

emergo asia pacific pty ltd t/a emergo australia - 61324 - bone-screw internal spinal fixation system, sterile - the device is intended for use as a posterior pedicle screw system (t1-s2/ilium), or as an anterolateral fixation system (t8-l5), 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: 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); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis; and failed previous fusion (pseudoarthrosis).

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

david le cheminant - 61325 - bone-screw internal spinal fixation system, non-sterile - invictus spinal fixation system & invictus mis system: the invictus spinal fixation system & invictus mis system are intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin 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; pseudarthrosis; and/or failed previous fusion. when used for posterior non-cervical pedicle screw fixation in pediatric patients, the invictus spinal fixation system & invictus mis system implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. additionally, the invictus spinal fixation system & invictus mis system are intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. pediatric pedicle screw fixation is limited to a posterior approach. the invictus spinal fixation system & invictus mis system are intended to be used with autograft and/or allograft. invictus oct spinal fixation system: the invictus oct spinal fixation system is intended to provide immobilization and stabilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (c1 to c7), and the thoracic spine from t1-t3: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g.,pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. the invictus oct spinal fixation system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. in order to achieve additional levels of fixation, the invictus oct spinal fixation system may be connected to the invictus spinal fixation system offered by alphatec spine using various rod-to-rod connectors and/or transitional rods. invictus osseoscrew system: the invictus osseoscrew system is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

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

alphatec australia pty ltd - 60762 - polymeric spinal fusion cage, non-sterile - transcend nanotec cervical interbody system: the transcend cervical peek interbody system with advanced nanotec surface treatment is an anterior cervical interbody fusion system intended for use in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, ct, mri), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from c2-t1. the transcend nanotec cervical interbody system is intended for use with supplemental fixation systems. the system is designed for use with autograft, allograft composed of cortical, cancellous and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof. transcend peek interbody system and transcend nanotec interbody system: the transcend peek interbody system and transcend nanotec interbody system with advanced nanotec surface treatment are indicated for spinal fusion procedures from tl to s1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (ddd), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. ddd is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. additionally, the transcend peek interbody system and transcend nanotec interbody system can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. the transcend peek interbody system and transcend nanotec interbody system are intended for use on patients who have had at least six months of non-operative treatment. it is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate and supplemental fixation systems for use in the thoracic and lumbar spine. amp anti-migration plate may be used with transcend lif interbody spacers to provide integrated fixation. transcend lif spacers with >20? lordosis must be used with amp anti-migration plate in addition to supplemental fixation. transcend alif interbody spacers with >20? lordosis must be used with an anterior plate as the form of supplemental fixation.

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

david le cheminant - 46653 - spinal fixation plate, non-biodegradable - a cervical plating system designed to be used from c2-t1 for the following indications: for degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

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

alphatec australia pty ltd - 38161 - spinal cage - identiti cervical porous ti interbody system & identiti nanotec cervical platform: the identiti cervical porous ti interbody system and identiti cervical interbody system with advanced nanotec surface treatment are an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, ct, mri), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from c2-t1. the identiti cervical porous ti interbody system and identiti nanotec cervical porous ti interbody system are intended for use with supplemental fixation systems. the systems are designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof. identiti porous ti lnterbody system & identiti nanotec thoracolumbar platform: the identiti porous ti lnterbody system and identiti lnterbody system with advanced nanotec surface treatment are indicated for spinal fusion procedures from t1 to s1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (ddd), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. ddd is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. additionally, the identiti porous ti lnterbody system and identiti nanotec interbody system can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. the identiti porous ti lnterbody system and identiti nanotec lnterbody system are intended for use on patients who have had at least six months of non-operative treatment. it is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate and supplemental fixation systems that are for use in the thoracic and lumbar spine. amp anti-migration plate may be used with identiti lif and identiti nanotec lif interbody spacers to provide integrated fixation. identiti lif spacers with >20? lordosis must be used with amp anti-migration plate in addition to supplemental fixation. identiti alif interbody spacers with >20? lordosis must be used with an anterior plate as the form of supplemental fixation.

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

medacta australia pty ltd - 61324 - bone-screw internal spinal fixation system, sterile - device intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (c1 to c7) and the thoracic spine from t1 to t3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. this device is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.