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

e4 surgical pty ltd - 44805 - orthopaedic surgical cutter - insert spreaders and shavers into the disc space to cut and shape the bone to either a specified shape or to match an implant size.

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

e4 surgical pty ltd - 35559 - rasp, surgical, bone - used to remove spinal disc material, tissue or muscle that surrounds bone by cutting or scrapping.

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

e4 surgical pty ltd - 32873 - tamp, surgical - inserted into the disc space to pack and fill the disc space with bone graft/bone substitute at the end of surgery. end of shaft is normally impacted with a mallet supplied by the hospital to further pack the bone into the disc space.

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

e4 surgical pty ltd - 44054 - surgical procedure kit, orthopaedic, reusable - instrument kit used during spinal surgery

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

e4 surgical pty ltd - 47022 - spinal curette - used to cut spinal disk material, tissue or muscle that surrounds bone.

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

e4 surgical pty ltd - 45918 - wound retractor, intermediate/deep - class 1 retractor blades used to assist surgeons access spinal column during spinal surgery.

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

e4 surgical pty ltd - 38161 - spinal cage - spinal cage intended for reconstruction of anterior spinal column defects. indications include: - vertebral body destruction with kyphosis - segmental instability - stabilization after treatment of a herniated cervical intervertebral disc - osteophytosis compressing the nerve roots and/or spinal cord - degenerative intervertebral instability - degenerative disc diseases and spinal instability - cervical spine trauma - radiculopathy - myelopathy - osteomyelitis

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

e4 surgical pty ltd - 45253 - orthopaedic cement preparation/delivery kit - sterile single use prepartaion instruments for bone filling container kit.

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

e4 surgical pty ltd - 61325 - bone-screw internal spinal fixation system, non-sterile - the precision spine reform poct 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 craniocervical junction, the cervical spine (c1 to c7) and the thoracic spine from 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 precision spine reform poct 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.

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

e4 surgical pty ltd - 61325 - bone-screw internal spinal fixation system, non-sterile - the reform 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). the reform pedicle screw system is also intended for non-cervical pedicle screw fixation for the following indications: 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 lumbar and sacral spine (l3 to sacrum) with removal of the implants after the attainment of a solid fusion. it is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.