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

globus medical australia pty ltd - 37272 - fixation device, internal, spine, construct - the acadia? system consists of superior and inferior facet joint implants made from cobalt chromium alloy with captive titanium and peek polyaxial locking components. the regions of the implant that contact bone have titanium plasma spray and hydroxyapatite coated ingrowth surfaces. the implants are compatible with the acadia? pedicle screws, top nut, cross-link clamps and cross-bar (all titanium). the complete acadia? instrument system is required to successfully perform the procedure. the acadia? implant is intended for use in patients with lateral, lateral recess and/or central canal stenosis at the l3 to s1 level who require a complete facetectomy and have failed six months of conservative treatment.

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

globus medical australia pty ltd - 35642 - fixation system, internal,fracture, non-biodegradable - the ellipse? occipito-cervico-thoracic spinal system is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-t3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors. the use of polyaxial screws is limited to placement in the upper thoracic spine (t1-t3) in treating thoracic conditions or placement in the cervical spine (c1-c7) in treating cervical conditions. occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine. the ellipse? occipito-cervico-thoracic spinal system 3.5mm rods can also be

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

globus medical australia pty ltd - 35642 - fixation system, internal,fracture, non-biodegradable - for use in the treatment of thoracolumbar spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

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

globus medical australia pty ltd - 46653 - spinal fixation plate, non-biodegradable - to provide anterior screw fixation to the cervical spine.

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

globus medical australia pty ltd - 35642 - fixation system, internal,fracture, non-biodegradable - the citadel? anterior lumbar plate system is intended for use by an anterior or anterolateral approach in the treatment of lumbar and lumbosacral (l1-s1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

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

globus medical australia pty ltd - 35642 - fixation system, internal,fracture, non-biodegradable - the vip? anterior cervical plate system is intended for anterior screw fixation to the cervical spine c2- c7 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 (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis and spinal stenosis.

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

globus medical australia pty ltd - 48165 - lumbar total disc replacement prosthesis - for spinal arthroplasty in treating patients with degenerative disc disease, primary or recurrent disc herniation, spinal stenosis, or spondylosis in the lumbosacral spine.

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

globus medical australia pty ltd - 48165 - lumbar total disc replacement prosthesis - the triumph? lumbar disc is comprised of a implant assembly inserted using an anterior approach. the assembly consists of a superior and inferior endplate with keels and a moving polyethylene core. the implant is offered in a variety of configurations to accommodate varied patient anatomy. the triumph? lumbar disc is indicated for spinal arthroplasty in treating skeletally mature patients with degenerative disc disease, primary or recurrent disc herniation, spinal stenosis, or spondylosis in the lumbosacral spine (l1-s1). ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, with or without leg (radicular) pain. patients may have spondylolisthesis up to grade 1 at the involved level.

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

globus medical australia pty ltd - 16966 - graft, bone, synthetic - microfuse granules can be gently packed into contained voids or defects. microfuse sheets and rods can be used with shallow bony defects, or as a bone graft onlay to cover a defect. microfuse is made from resorbable, radiolucent polymer and provides an osteoconductive scaffold that can wick and hold osteogenic fluids such as bone marrow aspirate and allows bone growth into and through the implant. microfuse? bone void filler is intended for use in filling bony voids or gaps of the extremities, spine and pelvis. these osseous defects may be surgically created or created from traumatic injury to the bone. microfuse may be mixed with a variety of graft materials including autograft, allograft, bone marrow aspirate, bone growth factors, and platelet rich plasma. microfuse? provides a bone void filler that resorbs and is replaced with bone during the healing process.

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

globus medical australia pty ltd - 35210 - needle, blunt, single use - a slender instrument used for puncturing tissues or blood vessels, suturing, injection or aspiration