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

medtronic australasia pty ltd - 46425 - bone matrix implant, animal-derived, bioabsorbable - mastergraft? putty is supplied as a sterile, dry, solid, construct that is hydrated for single patient use and is a mouldable form of bone void filler. mastergraft? products are biocompatible, osteoconductive, porous implants that allows for bony in growth across the graft site while resorbing at a rate consistent with bone healing. mastergraft? putty is intended to help fill voids or gaps in bone, which may be surgically created osseous defects, or osseous defects caused by traumatic injury to the bone. mastergraft? putty provides a bone void filler that is resorbed and is replaced with bone during the natural healing process. the putty when combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. additionally, mastergraft putty can be used with autograft as a bone extender. specific indications for use include oral/maxillofacial augmentation or reconstruction.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - the atlantis™ anterior cervical system components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine. the indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. 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.

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

medtronic australasia pty ltd - 61555 - radio-frequency ablation system probe cannula, reusable - reusable rf probe is an individual electrode used in combination with an rf cannula for rf energy delivery. it delivers radiofrequency (rf) through the active tip of the rf cannula.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - cd horizon legacy system hydroxyapatite (ha) coated multi-axial screws are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - the cd horizon® spinal system is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. it is indicated for used in a percutaneous posterior approach with the sextant instrumentation; used as a pedicle screw fixation system for skeletally mature patients; and used as a posterior spine thoracic/lumbar system.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - when used in a percutaneous posterior approach with sextant instrumentation, the components are intended for the following indications: as a pedicle screw fixation system it is indicated for skeletally mature patients: having severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (l5-s1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine (l3 and below); or, who are having the device removed after the development of a solid fusion mass. when used as a posterior spine thoracic/lumbar system, the components are intended for: degenerative disc disease; spinal stenosis; spondylolisthesis; spinal deformities; fracture; pseudarthrosis; tumor resection; and/or failed previous fusion.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - it is intended for use in the lower cervical and upper thoracic spine (c3 to t3) in laminoplasty procedures. it is used to hold the graft material in place in order to prevent the gradt material from expulsion, or impinging the spinal cord.

Singapore - engelsk - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - it is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one level from l2-s1. ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. these ddd patients also have up to grade i spondylolisthesis or retrolisthesis at the involved level. lt-cage™ peek implants are to be used with autogenous bone graft and implanted via a laparoscopic or an open anterior approach. patients receiving the lt-cage™ peek lumbar tapered fusion device should have at least six months of non-operative treatment prior treatment with the lt-cage™ peek device