Australia - English - 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.

Australia - English - 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.

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

globus medical australia pty ltd - 46653 - spinal fixation plate, non-biodegradable - the resonate? anterior cervical plate system is intended for anterior screw fixation to the cervical spine (c2-t1) for the following indications: 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)

globus medical australia pty ltd - 46281 - cranial hand drill, single-use - excelsiusgps cranial solutions instruments are indicated for the placement of intracranial devices such as biopsy needles, electrodes, and tubes.

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

globus medical australia pty ltd - 35095 - surgical drill guide, reusable - the cranial adjustable drill guide is used to guide and control drill depth in excelsiusgps cranial procedures to aid in the placement of intracranial devices such as biopsy needles, electrodes, and tubes.

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

globus medical australia pty ltd - 45169 - stereotactic surgery system probe, reusable - excelsiusgps cranial solutions instruments are indicated for the placement of intracranial devices such as biopsy needles, electrodes, and tubes.

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

globus medical australia pty ltd - 38161 - spinal cage - sable? expandable spacer is a 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 sable? expandable spacer is to be filled with autogenous bone graft material, bone graft extenders, and/or bone graft substitutes. the device is intended to be used with supplemental fixation.

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

globus medical australia pty ltd -

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

globus medical australia pty ltd -

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

globus medical australia pty ltd -