Australia - English - 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 use in skeletally mature patients with degenerative disc disease (ddd) of the cervical 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. the system is used to facilitate intervertebral body fusion in the cervical spine at the c3 to c7 disc levels using autograft bone. the system is to be used with supplemental fixation. patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Australia - English - 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.

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

emergo asia pacific pty ltd t/a emergo australia - 61325 - bone-screw internal spinal fixation system, non-sterile - the system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. the system can be used in an open approach and a percutaneous approach. the system is intended for the following indications: - degenerative disc disease (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, lordosis) - tumor - pseudarthrosis - failed previous fusion

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

emergo asia pacific pty ltd t/a emergo australia - 61325 - bone-screw internal spinal fixation system, non-sterile - the system is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (t1-s2/ilium), or as an anterolateral fixation system (t8-l5). all components in the system are limited to skeletally mature patients. these devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

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

emergo asia pacific pty ltd t/a emergo australia - 61325 - bone-screw internal spinal fixation system, non-sterile - the system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (c1 to c7) and the thoracic spine (t1-t3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. the system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. the system can be linked to the spinal fixation system and posterior cervical fixation system via rod to rod connector and transitional rod.

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

emergo asia pacific pty ltd t/a emergo australia - 44316 - hand-held telescope - the external telescope simulator (ets) is designed to provide candidates for imt with visual experience that mimics the wide angle (wa) device.

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

emergo asia pacific pty ltd t/a emergo australia - 17888 - thermometer, infrared, skin - the device is intended for use in measuring temperature in adult population, children and babies population. this device is not suitable for children born before term.

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

emergo asia pacific pty ltd t/a emergo australia - 57803 - penile extracorporeal shock wave therapy system - the device is a transportable extracorporeal shockwave therapy device intended to deliver low intensity shockwaves to target regions. the device incorporates electromagnetic (em) transducers mountable on articulated arms for positioning relative to the target regions. the device is intended for the treatment of erectile dysfunction (ed).

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

emergo asia pacific pty ltd t/a emergo australia - 47841 - soft corrective contact lens, daily-disposable - the soft contact lenses are indicated for 1-day wear to correct visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia. the lens may be worn by persons who exhibit refractive astigmatism of - 0.50 diopters or less where the astigmatism does not interfere with visual acuity. the lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Australia - English - 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.