অস্ট্রেলিয়া - ইংরেজি - 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 intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from c2-t1. the system is intended to be used with or without supplemental fixation. the system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion.

অস্ট্রেলিয়া - ইংরেজি - 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 intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from c2-t1. the system is intended to be used with or without supplemental fixation. the system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion.

অস্ট্রেলিয়া - ইংরেজি - 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.

অস্ট্রেলিয়া - ইংরেজি - 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.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

connexion surgical pty ltd - 17751 - bone matrix implant, synthetic - magnetos putty is a synthetic tri-calcium phosphate and hydroxyapatite resorbable micro-structured bone void filler for the repair of bony defects. the product consists of granules, premixed with a synthetic polymeric binder that provides cohesion between the granules. magnetos putty has a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. magnetos putty is intended for use as bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. magnetos putty is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. magnetos putty is intended to be packed into bony voids or gaps of the skeletal system (i.e. extremities, spine, cranial, mandible, maxilla and pelvis) and may be combined with autogenous bone.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

connexion surgical pty ltd - 17751 - bone matrix implant, synthetic - magnetos is a synthetic, tri-calcium phosphate and hydroxyapatite resorbable micro-structured bone void filler for the repair of bony defects. magnetos has a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. magnetos is intended for use as bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. magnetos is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. magnetos is intended to be packed into bony voids or gaps of the skeletal system (i.e. extremities, spine, cranial, mandible, maxilla and pelvis) and may be combined with autogenous bone, blood, prp and/or bone marrow.

অস্ট্রেলিয়া - ইংরেজি - 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.

অস্ট্রেলিয়া - ইংরেজি - 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.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

globus medical australia pty ltd - 38161 - spinal cage - hedron c? spacers and hedron ic? spacers are interbody fusion devices indicated at one or more levels of the cervical spine (c2-t1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed with radiographic studies. these patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. hedron c? spacers and hedron ic? spacers are recommended to be used with supplemental fixation systems for the cervical spine, (e.g. anterior cervical plates). these spacers are to be filled with autogenous bone graft material, bone graft extender, and/ or bone graft substitutes. when the hedron ic? spacer is used with the coalition agx? plate, the plate-spacer assembly (hedron ic? plate-spacer)is a stand-alone device intended for use at one or more levels of the cervical spine (c2-t1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. these devices are to be used with two titanium screws which accompany the implant. the spacer is to be filled with autogenous bone graft material, bone graft extender, and/or bone graft substitutes.

অস্ট্রেলিয়া - ইংরেজি - 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.