Singapore - English - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - the nuvasive cohere thoracolumbar interbody system is indicated for intervertebral body fusion of the spine in skeletally mature patients. the system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. when used with or without the cohere xlif internal fixation, the system is indicated for use with supplemental spinal fixation systems for use in the thoracolumbar spine. the devices are to be used in patients who have had at least six months of non-operative treatment. the nuvasive cohere thoracolumbar interbody system is intended for use in interbody fusions in the thoracic spine, from t1 to t12, and at the thoracolumbar junction (t12-l1), and in the lumbar spine, from l1 to s1, for the treatment of symptomatic disc disease (ddd) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). ddd is defined as bac

Singapore - English - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - the brigade standalone system is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one or two contiguous levels in the lumbar spine (l2 to s1). ddd is defined as back pain of dicogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. ddd patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s).the brigade standalone system is intended for use with autograft. the brigade standalone system (lordotic angles 8◦ to 12◦) is a standalone system.patients must have undergone a regimen of at least six(6) months of non-operative treatment prior to being treated with the brigade standalone system.

Singapore - English - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - when used as a pedicle screw fixation system, it 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 posterior thoracic, lumbar, and sacral spine: degenerative disc disease, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and/or failed previous fusion (pseudoarthrosis). it is also indicated for the treatment of severe spondylolisthesis (grades 3 and 4) of the l5-s1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (l3 to sacrum), with removal of the implants after attainment of a solid fusion. when used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, it is also intended for: degenerative disc disease, spinal stenosis

Singapore - English - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - attrax is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. attrax is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. attrax is intended to be packed into bony voids or gaps of the skeletal system as bone void filler (i.e. spine and pelvis) and as autologous bone graft extender in the spine. attrax should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously. in load bearing situations, attrax is to be used in conjunction with internal or external fixation devices.

Singapore - English - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - the brigade hyperlordotic system(lordotic angles 15◦ to 30◦) is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one or two contigious levels in the lumbar spine (l2 to s1).ddd is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.ddd patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. these patients may have had a previous non-fusion spinal surgery at the involved level(s). the brigade hyperlordotic system is intended for use with autograft.the brigade hyperlordotic system must be used with supplemental internal spinal fixation systems(i.e.posterior pedicle screw and rod system).patients must have undergone a regimen of at least six(6) months of non-operative treatment prior to being treated with the brigade hyperlordotic system

Singapore - English - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - it 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.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. it may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (t1 to l5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. the system is intended to be used with supplemental internal spinal fixation systems.

Singapore - English - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - it is indicated for intervertebral body fusion of the spine in skeletally mature patients and is designed for use with autogenous bone graft to facilitate fusion. 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. it is to be used in patients who have had at least six weeks of non-operative treatment and is intended to be used with supplemental fixation and autogenous bone graft only to facilitate the fusion. it may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (t1 to l5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. the system is intended to be used with supplemental internal spinal fixation systems.

Singapore - English - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - it 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. 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. it may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (t1 to l5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. the system is intended to be used with supplemental internal spinal fixation systems

Singapore - English - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - formagraft is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. the product should be gently packed into bony voids or gaps of the skeletal system (i.e, the extremities, spine and pelvis). these defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. the product provides bone void filler that resorbs and is replaced by the growth of new bone during the healing process. the bone graft can be mixed with autogenous bone marrow prior to use at the physician’s discretion. in weight bearing situations, formagraft is to be used in conjunction with internal or external fixation devices. the fracture defect treated with formagraft should not exceed 30 ml.

Singapore - English - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - manually operated devices indicated for use during spinal surgical procedures.