Singapore - engelsk - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - the nuvasive nuvaline mobile app is a medical device software mobile application intended to assist healthcare professionals in capturing, measuring, and storing spinal alignment assessment images at various time points in patient care. the device allows the healthcare professional to conveniently perform and review spinal alignment assessments of images by featuring measurement tools on their mobile device.

Singapore - engelsk - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - neurology - the nvm5® system provides surgeon-driven neurophysiologic electromyography (emg), motor evoked potential (mep), and somatosensory evoked potential (ssep) monitoring to nerve roots and the spinal cord during spinal procedures. bendini® is the nvm5 rod bending system used to bend rods for spinal surgery applications. the system is comprised of a camera and! digitizer to register implant locations, nvm5 software to calculate bend angles between each implant and generate bend instructions, and a mechanical bender to manually bend the rod to implant specific contours. nvm5 guidance incorporates accelerometers attached to both the c-arm and to the nuvasive® i-pas™ needle (accelerometers are microdevices that can measure trajectory) as well as lasers and a reticle that together assist in aligning the i-pas needle into the trajectory corresponding with the owl's eye view for pedicle cannulation.

Singapore - engelsk - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - nuvasive titanium mesh is a 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. nuvasive titanium surgical mesh is intended to be used with supplemental internal spinal fixation systems for use in the thoracic and lumbar spine.

Singapore - engelsk - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - 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.

Singapore - engelsk - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - 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 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 devices are to be used in patients who have had at least six weeks of non-operative treatment. the system is intended to be used with supplemental fixation and autogenous bone graft only to facilitate the fusion.

Singapore - engelsk - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. the nuvasive facet screw system is indicated for facet fixation, with or without bone graft, at single or multiple levels, from c2 to s1 (inclusive). the nuvasive radian facet screw system is indicated for treatment of any or all of the following: (a) pseudoarthrosis and failed previous fusion; (b) spondylolisthesis; (c) spondylolysis; (d) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; (e) degeneration of the facets with instability; and (f) fracture. the nuvasive radian facet screw system is intended for conventional or percutaneous surgical placement.

Singapore - engelsk - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - the nuvasive® affix™ spinous process plate system is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor. it is not intended for stand-alone use.

Singapore - engelsk - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - the nuvasive leverage lfs is intended for use in the lower cervical and upper thoracic spine (c3 to t3) in laminoplasty procedures. the leverage lfs is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.

Singapore - engelsk - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - neurology - the neurovision® system is intended for use in the operating room and non-critical care clinical environment for neurological monitoring and status assessment. the system may be used alone or in conjunction with other nuvasive® devices to assist in gaining controlled access to the spine.

Singapore - engelsk - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - neurology - the neurovision® system is intended for use in the operating room and non-critical care clinical environment for neurological monitoring and status assessment. the system may be used alone or in conjunction with other nuvasive® devices to assist in gaining controlled access to the spine.