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

globus medical australia pty ltd - 38723 - robot, surgical, navigation unit - the excelsius gps is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons for navigating or guiding standard surgical instruments in open or percutaneous procedures. the system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra can be identified relative to a ct-based model, fluoroscopy images, or digitized landmarks of the anatomy.

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

globus medical australia pty ltd - 48164 - cervical total disc replacement prosthesis - the secure-c cervical artificial disc is indicated for treatment of symptomatic cervical disc disease (scdd) from c3-c7. scdd is defined as neck or arm pain, or functional or neurological deficit confirmed by patient history and radiographic studies demonstrating primary or recurrent disc herniation, radiculopathy or myelopathy, spondylosis, spinal stenosis and/or loss of disc height.

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

globus medical australia pty ltd - 44796 - clinical measurer, ruler - a device used for exploratory or measuring purposes

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

globus medical australia pty ltd - 16101 - fixation device, internal, screw - the zyfuse? facet fixation system is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from l1 to s1. for transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. for translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. the zyfuse? facet fixation system is indicated for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of the facets with instability and trauma inclu

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

globus medical australia pty ltd - 37272 - fixation device, internal, spine, construct - to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

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

globus medical australia pty ltd - 37272 - fixation device, internal, spine, construct - the corridor? fixation system is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from t1 to s1, and to stabilize type ii odontoid fractures. for transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. for translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. for type ii odontoid fixation, one or two screws are inserted anteriorly through the c2 vertebral body and into the odontoid process. the corridor? fixation system is indicated for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative dis

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

globus medical australia pty ltd - 37272 - fixation device, internal, spine, construct - the revolve? stabilization system, when used as a posterior pedicle screw system, is intended 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), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion. in addition, the revolve? stabilization system is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the l5-s1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. levels of pedicle screw fixat

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

globus medical australia pty ltd - 37272 - fixation device, internal, spine, construct - revlok? fenestrated screw system, when used as posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in 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 disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment,fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion. in addition, revlok? fenestrated screw system is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the l5-s1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. levels of pedicle screw fixation for these

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

globus medical australia pty ltd - 37272 - fixation device, internal, spine, construct - fixation device, internal, spine construct [37272] the transition stabilization system is intended to provide spinal alignment and dynamic stabilization in skeletally mature patients in up to five contiguous levels of the thoracic, lumbar and sacral spine. the system is intended to be used for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, degenerative spondylolisthesis with objective evidence of neurologic impairment, spondylosis, spinal stenosis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

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

globus medical australia pty ltd - 37272 - fixation device, internal, spine, construct - the si-lok? sacroiliac joint fixation system is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.