Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

kh nxgen aus pty ltd - 61325 - bone-screw internal spinal fixation system, non-sterile - the ceplate anterior cervical plate system is indicated for stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (ddd) of the cervical spine, trauma, tumors, deformity, pseudoarthrosis and failed previous fusions. the system is intended for c2-c7.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

lmt surgical pty ltd - 38161 - spinal cage - interbody fusion with bone graft in patients with symptomatic degenerative disc disease (ddd). these implants may be implanted via an open or a minimally invasive posterior approach. alternatively, these implants may also be implanted via a transforaminal approach. these devices are intended to be used with supplemental posterior fixation. device is intended to be supplied sterile.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

3-d matrix medical technology pty ltd - 61958 - ceramic spinal fusion cage - novomax fusion is developed as implants for the stabilization of the anterior cervical spondylodesis. novomax fusion is indicated for use in patients with degenerative disc disease (ddd) of the cervical spine accompanying radicular symptoms at one level from c3 to t1. these patients should be skeletally mature and have six (6) weeks of non-operative therapy. novomax fusion is to be implanted via an anterior approach. novomax cervical intervertebral body fusion devices are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., screw and plate systems).

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

rti surgical australia pty ltd - 60762 - polymeric spinal fusion cage, non-sterile - these?devices?are?indicated?for?use?in?skeletally?mature?patients?with?degenerative?disc?disease?(ddd)?of?the?cervical?or thoracolumbar spine?with?accompanying? radicular?symptoms?at one or two contiguous?levels. these?ibf?devices?are?used?to?facilitate?interbody?fusion?in?the: -?cervical?spine?and?are?placed?via?an?anterior?approach?from?c2-c3?to?c7-t1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or?corticocancellous?bone?graft.? -?lumbar?spine?from?l1-l2?to?l5- s1 using autogenous bone?graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone?graft?to?facilitate?fusion.? the?ibf?devices?are?intended?to?be?used?with?supplemental?fixation?cleared?for?the?implanted?level. the devices are supplied sterile.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 60762 - polymeric spinal fusion cage, non-sterile - a device intended for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (ddd) at one or two contiguous levels from l2 to s1, following discectomy.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 38161 - spinal cage - a device intended for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (ddd) at one or two contiguous levels from l2 to s1, following discectomy.

Austrália - angličtina - 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.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

alphatec australia pty ltd - 38161 - spinal cage - the identiti standalone interbody system is indicated for spinal fusion procedures in one or two contiguous levels in skeletally mature patients. identiti alif standalone interbody system: for use in the lumbar spine (l2-s1) for the treatment of degenerative disc disease (ddd). the identiti alif standalone interbody system implants of ?20? are a standalone system. the identiti alif standalone interbody system implants of >20? must be used with supplemental spinal fixation systems for use in the lumbar spine in addition to the integrated screws. identiti cervical standalone interbody system: is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at levels (c2-t1). the identiti cervical standalone interbody system is intended to be used with the bone screw fixation provided andrequires no additional fixation.

Austrália - angličtina - 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.

Austrália - angličtina - 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.