Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 60762 - polymeric spinal fusion cage, non-sterile - the system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one or two contiguous levels from l2-s1. ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. these ddd patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s).this device is to be used with autogenous bone graft. the system is to be used with supplemental fixation. patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

evolution surgical pty ltd - 48165 - lumbar total disc replacement prosthesis - intended to replace the lumbar disc in patients with symptomatic degeneratice disc disease (ddd) at lumbar levels l3-s1. a symptomatic degenerative disc is defined as back pain associated with structural changes confirmed by patient history and radiographic studies. intended for use only if conservative care fails to reduce symptoms.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 61325 - bone-screw internal spinal fixation system, non-sterile - intended for anterior/anterolateral and posterior, pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (ddd) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 61324 - bone-screw internal spinal fixation system, sterile - intended for percutaneous, posterior, non cervical pedicle and non pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (ddd) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 61325 - bone-screw internal spinal fixation system, non-sterile - intended for percutaneous, posterior, noncervical pedicle and nonpedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (ddd) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e.,scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 60762 - polymeric spinal fusion cage, non-sterile - an intervertebral body fusion device. indicated for use with autogenous bone graft in patients with degenerative disc disease (ddd) at one level or two contiguous levels from l2 to s1. ddd is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. ddd patients may also have up to grade i spondylolisthesis at the involved level(s). these patients should be skeletally mature and have six months of nonoperative therapy. implanted via an open, anterior approach. may be used as a stand-alone device or in conjunction with supplemental fixation. when used as a stand-alone device, the cage must be used with the internal screw and plate fixation provided. if used with less than three or none of the provided screws, then additional supplemental fixation that has been approved for use in the lumbar spine must be used to augment stability. the accompanying locking plate must be used anytime the device is used with any number of screws.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

biomet 3i australia pty ltd - 61325 - bone-screw internal spinal fixation system, non-sterile - an assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities. may also be used to promote spinal fusion for degenerative disc disease (ddd).

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 43257 - fixation system, internal, spinal, bone screw - the versalink? fixation system is intended to treat l1 to s1 spinal lumbar pathologies that require decompression of the spinal canal and restoration of the segment stability by an instrumented fixation performed in a posterior surgical approach. the system is intended for single or multi level pathologies, indicated for spinal fusion procedures in skeletally mature patients that require stabilization for pathologies including degenerative disc disease (ddd), disc herniation, lumbar spinal stenosis and, spondylolisthesis (up to grade 1). the system is intended to be used with or without anterior interbody support and autogenous bone graft (placed from a posterior approach only). the system consists of a ring nut, upright rod, ring set screw, crossbar rod and polyaxial pedicle screws. the versalink? fixation system is to be used only with tops? system's pedicle screws supplied by premia spine.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

lmt surgical pty ltd - 38161 - spinal cage - amendia intervertebral body fusion devices are indicated for use in skeletally mature patients with degenerative disc disease (ddd) of the cervical and lumbar 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. for lumbar fusion, these ddd patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level. these implants are to be used with autogenous bone graft and implanted via various approaches. the intervertebral cages are to be used with supplemental fixation. patients should have at least six (6) weeks (cervical fusion) or six (6) months (lumbar fusion) of non-operative treatment prior to treatment with an intervertebral cage.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 38161 - spinal cage - intervertebral body fusion the nuvasive coroent system is indicated for intervertebral body fusion of the spine in skeletally mature patients. the system is designed for use with autogenous bone graft to facilitate fusion. the coroent l and xl platforms are intended for use at either one level or two contiguous levels in the lumbar spine, from l2 to s1, for the treatment of degenerative disc disease (ddd) with up to grade i spondylolisthesis. ddd is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. the lumbar devices are to be used in patients who have had at least six months of non-operative treatment. the system is intended to be used with supplemental internal spinal fixation systems that are cleared by the fda for use in the lumbar spine. the coroent s platforms are intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (ddd) at one level from levels c2-c3 to c7- t1. the cervical devic