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

nuvasive (aust/nz) pty ltd - 43257 - fixation system, internal, spinal, bone screw - the nuvasive systems are intended to provide immobilisation and stabilisation 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 posterior thoracic, lumbar, and sacral spine: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and/or failed previous fusion (pseudoarthrosis). the nuvasive systems are also indicated for the treatment of severe spondylolisthesis (grades 3 and 4) of the l5-s1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (l3 to sacrum), with removal of the implants after attainment of a solid fusion.

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

stryker australia pty ltd - 57805 - spinal fusion cage, non-sterile - when used as a cervical intervertebral body fusion device, the implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. the implants are intended for use for the treatment of cervical disc disease. the cervical device is intended to be used in patients who have had six weeks of non-operative treatment. when used as a lumbar intervertebral body fusion device, the implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. the implants are intended for the treatment of degenerative disc disease. the lumbar device is intended to be used in patients who have had six months of non-operative treatment. when used as vertebral body replacement devices the implants are indicated for use in the thoracolumbar spine for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decom

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

medtronic australasia pty ltd - 16966 - graft, bone, synthetic - resorbable, nanocrystalline hydroxyaphatite bone grafting solution with osteoconductive properties that enhances new bone formation and stimulates bone healing. it is a non-hardening, calcium phosphate product set in a matrix of sterile water. the water based nature of this paste allows blood to easily integrate into the nanostructure of the material, which leads to faster vascularisation and cell migration. nanostim is a highly viscous, resorbable bone substitute for the filling of bone defects and bone graft extension in autogenous and allogenic cancellous bone transplantation. nanostim is indicated for use in orthopaedics and traumatology to fill and reconstruct bone defects resulting, for example, from: fractures; resection of benign tumours or cysts; harvesting of autogenic grafts; to fill metaphyseal bone defects. nanostim can be used as an extender for autogenic or allogenic bone grafts.

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

stryker australia pty ltd - 60762 - polymeric spinal fusion cage, non-sterile - the implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

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

life healthcare pty ltd - 34170 - prosthesis, internal, spine, vertebral body - when used as a vertebral body replacement, the x-spine calix system is intended for use in the thoracic and/or thoracolumbar spine to replace a collapsed, damaged or unstable vertebral body resected or excised due to tumour or trauma. the calix device, when used as a vertebral body replacement, can be packed with either allograft or autograft. when used as an intervertebral body fusion device, the x-spine calix system is intended for spinal fusion procedures at one level (c3-c7) in skeletally mature patients with degenerative disc disease. implants are to be implanted via an open, anterior approach and packed with autogenous bone.

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

stryker australia pty ltd - 35276 - prosthesis, internal, tendon sheath - these implants are intended for use in stage one of a two stage procedure for significant hand tendon injuries. it is intended to be implanted temporarily to encourage the formation of a pseudosynovial sheath which will later nourish and lubricate an autogenous tendon graft.removal is between 2 and 6 months.

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

medacta australia pty ltd - 38161 - spinal cage - the implants, in combination with a pedicle system, are indicated to use with autogenous bone graft in patients with degenerative disc disease (ddd) at one or two spinal levels from l2-s1 whose condition requires the use of interbody fusion combined with supplemental internal fixation e.g. pedicle screw fixation. these patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). the device provides mechanical stability and sufficent space for spinal bone fusion to occur. it helps to relieve pressure on pinched nerves and prevents vertebral slipping.

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

globus medical australia pty ltd - 38161 - spinal cage - patriot? spacers (colonial? acdf) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (ddd) of the cervical spine (c3-t1) at one or more levels. ddd is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. patriot? spacers are to be filled with autogenous bone graft material. these devices are intended to be used with supplemental fixation, such as the assure? or providence? anterior cervical plate system.

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

globus medical australia pty ltd - 38161 - spinal cage - the coalition? spacer is a stand-alone interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (ddd) of the cervical spine (c3-t1) at one level. ddd is defined as discogenic 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) weeks of non-operative treatment. the coalition? spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.

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

globus medical australia pty ltd - 38161 - spinal cage - caliber? spacers are interbody fusion devices intended for use in patients with degenerative disc disease (ddd) at one or more 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). caliber? spacers are to be filled with autogenous bone graft material. these devices are intended to be used with supplemental fixation, such as the revere or revolve stabilization systems.