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

evolution surgical pty ltd - 46653 - spinal fixation plate, non-biodegradable - the choice spine plates are spinal implants for surgical stabilisation of the anterior spine. the products are indicated for degenerative disc disease (ddd) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

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

evolution surgical pty ltd - 61324 - bone-screw internal spinal fixation system, sterile - the z-medical screw and rod products are used for the surgical stabilisation of the spine. the z-pedicle screws are indicated for fixation, reconstruction and stabilization of vertebrae for treatment of degenerative disc disease (ddd) (defined as backpain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, spinal stenosis, curvatures (scoliosis, kyphosis and / or lordosis), tumour, pseudoarthrosis and failed previous fusion.

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

emergo asia pacific pty ltd t/a emergo australia - 60762 - polymeric spinal fusion cage, non-sterile - this system is indicated for use in skeletally mature patients with degenerative disc disease (ddd) of the cervical spine with accompanying radicular symptoms at one disc level. ddd is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. this system is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the c3 to c7 disc levels using autograft bone. this system is to be used with supplemental fixation. patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. this system is for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ddd) of the lumbar spine at one or two contiguous levels from l2-s1. degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. these ddd patients may have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). this system is to be used with autogenous bone graft and implanted via a transforaminal, open posterior or lateral approach. this system to be used with supplemental fixation. patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.

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

emergo asia pacific pty ltd t/a emergo australia - 38161 - spinal cage - this system is ind icated for use in skeletally mature patients with degenerative disc disease (ddd) of the cervical spine with accompanying radicular symptoms at one disc level. ddd is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. this system is used to facilitate intervertebral body fusion in the cervical spine at the c3 to c7 disc levels using autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone. this system is to be used with supplemental fixation that has been cleared/approved for use in the cervical spine. these hyperlordotic intervertebral body fusion cervical cages (?10?) are required to be used with an anterior cervical plate as the form of supplemental fixation. patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. this system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ddd) of the lumbar spine at one or two contiguous levels from l2-s1. degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. these ddd patients may have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). this system is to be used with autogenous bone or allograft bone comprised of cancellous and/or corticocancellous bone. this system is to be used with supplemental spinal fixation systems that have been cleared/approved for use in the lumbosacral spine. these hyperlordotic intervertebral body fusion lumbar cages (?20?) should be used with anterior supplemental fixation (e.g., an anterior lumbar plate). patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Singapur - angličtina - HSA (Health Sciences Authority)

globus medical singapore pte. ltd. - orthopaedics - the elsa® spacer is a stand-alone lateral lumbar interbody fusion device intended for use in patients with degenerative disc disease (ddd) at one or more contiguous levels of the lumbosacral spine (l2-s1). ddd is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. these patients should be skeletally mature and have had at least six (6) months of non-operative treatment. in addition, these patients may have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). the elsa® spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.

Singapur - angličtina - HSA (Health Sciences Authority)

globus medical singapore pte. ltd. - orthopaedics - the elsa® spacer is a stand-alone lateral lumbar interbody fusion device intended for use in patients with degenerative disc disease (ddd) at one or more contiguous levels of the lumbosacral spine (l2-s1). ddd is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. these patients should be skeletally mature and have had at least six (6) months of non-operative treatment. in addition, these patients may have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). the elsa® spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.

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

globus medical australia pty ltd - 38161 - spinal cage - hedron? lumbar spacers (hedron a?, hedron l?, hedron p?, hedron t?, and hedron rt?) are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (t1-t12), thoracolumbar junction (t12-l1), or lumbosacral spine (l1-s1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (ddd), disc herniation(with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). ddd is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. these patients should be skeletally mature and have had at least six (6) months of non-operative treatment. hedron? lumbar spacers are to be filled with autogenous bone graft material, bone graft extenders, and/or bone graft substitutes. these devices are intended to be used with supplemental fixation systems for use in the thoracolumbosacral spine(e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). hedron ia? integrated lumbar spacers are integrated lumbar interbody fusion devices intended for use in patients with degenerative disc disease (ddd) at one or more contiguous levels of the lumbosacral spine (l2-s1). ddd is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. these patients should be skeletally mature and have had at least six (6) months of non-operative treatment. in addition, these patients may have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). hedron ia? spacers are to be filled with autogenous bone graft material,bone graft extenders, and/or bone graft substitutes. these devices are intended to be used with any combination of three screws and/or anchors which accompany the implants. when used without screws or anchors, hedron ia? spacers may be used as anterior lumbar interbody fusion devices to be used with supplemental fixation.

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

kh nxgen aus pty ltd - 44063 - surgical procedure kit, neurosurgical, single-use, non-medicated - the disposable spinal fixation instrument set is intended for pedicle fixation in a percutaneous approach for the following indications: 1)thoracolumbar vertebral fracture, 2)degenerative disc disease, 3)spondylolisthesis, 4)trauma (i.e., fracture or dislocation), 5)spinal stenosis, 6)curvatures, 7)pseudoarthrosis, 8)tumor, 9)failed previous fusion in mature patients 10)the instrument set 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.

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

stryker australia pty ltd - 38161 - spinal cage - an interbody fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (ddd) at one or two contiguous levels from l2-s1.

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

kh nxgen aus pty ltd - 44759 - fixation system implantation kit, internal - the instrument set 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 instruments listed are reusable.