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

medtronic australasia pty ltd - 58733 - sacroiliac joint arthrodesis implant - intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

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

medtronic australasia pty ltd - 47022 - spinal curette - the medical devices are intended for scraping or scoring of bone in the spine, including use during a balloon kyphoplasty procedure.

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

medtronic australasia pty ltd - 62404 - internal spinal fixation procedure kit, sterile - a collection of various sterile orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure; implants are not included. this is a single-use device.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - reusable instruments are intended for use in orthopedic and neurological surgical procedures to manipulate tissue, bone, or for use with other devices in surgery. an instrument may incorporate a measuring function, which has uses as described on the label and the instrument.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - reusable instruments are intended for use in orthopedic and neurological surgical procedures to manipulate tissue, bone, or for use with other devices in surgery. an instrument may incorporate a measuring function, which has uses as described on the label and the instrument.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - reusable instruments are intended for use in orthopedic and neurological surgical procedures to manipulate tissue, bone, or for use with other devices in surgery. an instrument may incorporate a measuring function, which has uses as described on the label and the instrument.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - general hospital - medtronic trimline® anterior cervical instrument set is designed specifically for standard anterior approaches.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - medtronic compact cornerstone-sr® anatomical cervical cage is a device intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - a copy of a final spinal prosthesis, graft, or other implantable device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. this trial device can be made of metal or plastic and is reusable.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - the artic-l™ 3d ti spinal system with tionic™ technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (ddd - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (l2-s1). additionally, the artic-l™ 3d ti spinal system with tionic™ technology can be used in patients diagnosed with spinal deformities as an adjunct to fusion. these patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. these implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. when used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.