Szingapúr - angol - HSA (Health Sciences Authority)

medtronic international, ltd. - general & plastic surgery - are intended to be used during preparation and placement of medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. medtronic surgical instruments are specifically designed for use with the mazor x stealth™ edition, which is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a ct or mr-based model, fluoroscopy images, or digitized landmarks of the anatomy. medtronic surgical instruments can be navigated or non-navigated manual instruments that may or may not be guided through the mazor x stealth™ edition arm guide. medtronic surgical drills shall only be used through the mazor x stealth™ edition arm guides, medtronic cannulas, and medtronic drill guides.

Szingapúr - angol - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - the medtronic t2 altitude™ expandable corpectomy system is a vertebral body replacement system intended for use in the thoracolumbar spine (t1-l5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). the t2 altitude™ expandable centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. the device is to be used with supplemental fixation. specifically, the construct is to be used with the vantage® anterior fixation system, the tsrh® spinal system, the cd horizon® spinal system, or their successors. additionally, the t2 altitude™ expandable corpectomy system is intended to be used with allograft and/or autograft.

Szingapúr - angol - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - this system is intended for anterior interbody screw fixation from c2 to t1. the system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.

Szingapúr - angol - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - the divergence-l anterior/oblique lumbar fusion system consists of plates, bone screws, and interbody cages. the interbody cage is intended to be used with supplemental fixation instrument for interbody fusion in patients with degenerative disc disease (ddd) at one or two contiguous levels from l2 to s1. these patients should be skeletally mature and have had six months of non-operative treatment. the interbody cage is also required to be used with autogenous bone graft. the plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior (l5-s1) or anterior oblique (l1-l5) in patients with: 1) degenerative disc disease (ddd); 2) trauma (including fractures); 3) tumors; 4) spinal deformity; 5) pseudarthrosis; and/or 6) failed previous fusions. when used together, the divergence-l anterior/oblique lumbar fusion system components can be used only to treat patients with ddd at one or two contiguous levels from l2 to s1.

Szingapúr - angol - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - the divergence™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from c2-t1. the plate and bone screw components are indicated for use in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2) trauma (including fractures); 3) tumors; 4) deformity (defined as kyphosis, lordosis, or scoliosis); 5) pseudoarthrosis; and/or 6) failed previous fusions. the divergence™ anterior cervical cage component and stand-alone interbody device are intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the c2-c3 disc to the c7-t1 disc.

Szingapúr - angol - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during a balloon kyphoplasty procedure with kyphon® hv-r® bone cement), hand, tibia, radius, and calcaneus.

Szingapúr - angol - HSA (Health Sciences Authority)

medtronic international, ltd. - general & plastic surgery - intended for ablation of benign bone tumors such as osteoid osteoma and palliative treatment by ablation of metastatic malignant lesions involving bone, including the vertebral body

Szingapúr - angol - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - the perimeter® interbody fusion device is indicated for interbody fusion with autogenous bone graft 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 1 spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. these implants may be implanted via a variety of open or minimally invasive approaches. these approaches include anterior, lateral and oblique. these devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Szingapúr - angol - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - the working ends are intended for drilling, tapping, or driving screws during spinal surgery, including open and minimally invasive procedures.

Szingapúr - angol - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - the rialto™ si fusion system is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.