Avstralija - angleščina - 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.

Avstralija - angleščina - 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.

Avstralija - angleščina - 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.

Avstralija - angleščina - 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.

Avstralija - angleščina - 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.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

globus medical australia pty ltd - 38161 - spinal cage - 'for use in the treatment of patients with degenerative disc disease (ddd) of the lumbosacral spine. ddd is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

globus medical australia pty ltd - 38161 - spinal cage - patriot? spacers (constitution? plif, continental? alif, transcontinental? llif and signature? tlif spacers) are interbody fusion devices intended for use in skeletally mature 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. in addition, these patients may have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). patriot? spacers are to be filled with autogenous bone graft material. these devices are intended to be used with supplemental fixation, such as the protex? or revere? stabilization system.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 38161 - spinal cage - the devices are indicated to use with autogenous bone graft in patients with degenerative disc disease (ddd) at one level c2-t1 whose condition requires the use of interbody fusion. these patients may have had a previous non-fusion spinal surgery at the involved spinal level. the devices provide mechanical stability and sufficient space for spinal bone fusion to occur. it helps to relieve pressure on pinched nerves and prevents vertebral slipping

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 38161 - spinal cage - the mectalif anterior is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (ddd) at one or two contiguous levels from l2 to s1. these ddd patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level(s). the interior of the spacer component of the mectalif anterior can be packed with autograft. the mectalif anterior is a stand-alone system intended to be used with bone screws provided and requires no additional supplementary fixation.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

globus medical australia pty ltd - 38161 - spinal cage - 'for use in the treatment of patients with degenerative disc disease (ddd) of the lumbosacral spine. ddd is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.