অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 38161 - spinal cage - intervertebral body fusion 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. 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 devic

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

ems oceania pty ltd - 47010 - ultrasonic dental surgical system - an assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. it is used for: periodontal surgery (osteotomy and osteoplasty, extraction of autogenous bone for regenerative surgery) implantology (alveolar ridge splitting, sinus lift, extraction of autogenous bone, implant site preparation) oral surgery(extraction, root resection, syndesmotomy, orthodontic surgery.) maxillary surgery (extraction of bone cylinders, osteogenetic distraction, nerve transposition, sinus elevation, distraction osteogenesis)

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

globus medical australia pty ltd - 37272 - fixation device, internal, spine, construct - beacon? stabilization system,when used as posterior pedicle screw systems,is intended to provide immobilization & stabilization of spinal segments in skeletally mature patients as adjunct to fusion in treatment of following acute & chronic instabilities or deformities of thoracic,lumbar & sacral spine:degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history & radiographic studies),degenerative spondylolisthesis with objective evidence of neurologic impairment,fracture,dislocation,scoliosis,kyphosis,spinal tumor,pseudoarthrosis & failed previous fusion.in addition,it is intended for treatment of severe spondylolisthesis (grades 3 & 4) of l5-s1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft,having implants attached to lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion.levels of pedicle screw fixation for these patients are l3-sacrum/ilium.when used as a posterior non-pedicle screw fixation system (using revere? hooks),it is intended for treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history & radiographic studies),spinal stenosis,spondylolisthesis,spinal deformities (i.e. scoliosis,kyphosis,and/or lordosis,scheuermann?s disease),fracture,pseudarthrosis,tumor resection,and/or failed previous fusion.overall levels of fixation are t1-sacrum/ilium.when used as an anterolateral thoracolumbar system,it is intended for anterolateral screw (with or without staple) fixation for following indications:degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies),spinal stenosis,spondylolisthesis,spinal deformities (i.e. scoliosis,kyphosis,and/or lordosis),fracture or dislocation of the thoracolumbar spine,pseudoarthrosis,tumor resection,and/or failed previous fusion.levels of screw fixation are t8-l5.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 34170 - prosthesis, internal, spine, vertebral body - the capstone control ptc spinal system is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease(ddd) at one or two levels from l2 to s1. these ddd patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. these patients should be skeleteally mature and have six months on non-operative treatment. these implants may be implanted via an open or a minimally invasive posterior approch. alternatively, these implants may also be implanted via an anterior and/or transforaminal approch. these implants are to be used with autogenous bone graft.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

southern implants australia pty ltd - 47968 - dental bone matrix implant, animal-derived - the anorganic bone matrix of zengro? has interconnecting macro- and microscopic porous structure that supports the formation and ingrowth of new bone at the implantation site. zengro? may be considered when autogenous bone is not indicated, or insufficient in quantity to fulfill the needs of the proposed surgical procedure. zengro is a sterile, biocompatible anorganic porous bone mineral for use in periodontal, oral and maxillofacial surgery. it is indicated as follows: - augmentation or reconstructive treatment of the alveolar ridge. - filling of infrabony periodontal defects. - filling of defects after root resection, apicoectomy, and cystectomy. - filling of extraction sockets to enhance preservation of the alveolar ridge. - elevation of the maxillary sinus floor. - filling of periodontal defects in conjunction with products intended for guided tissue regeneration (gtr) and guided bone regeneration (gbr). - filling of peri-implant defects in conjunction with products intended for guided bone regeneration (gbr).

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

globus medical australia pty ltd - 45181 - retractor system, self-retaining - indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, or harvesting autogenous bone.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

straumann pty ltd - 47968 - dental bone matrix implant, animal-derived - cerabone is presented in granular form and is used for filling bone defects and voids caused by removal of natural bone or as augmentation material in cases of autogenous cancellous bone grafting. cerabone(r) is a bone substitute material for permanent filling or reconstruction of aseptic bone defects in dental, oral and maxillofacial surgery. it is also indicated for the augmentation of material in cases of autogenous cancellous bone grafting in any of the specialty surgeries.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 61325 - bone-screw internal spinal fixation system, non-sterile - this system is intended to provide stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities of the spine: severe spondylolisthesis (grades 3 and 4) of the l5-s1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudo-arthrosis). this system is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (grades 3 and 4) of the l5-s1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft (levels of pedicle screw fixation are l3 to s1), and for whom the device is intended to be removed after solid fusion is attained. this system is also a sacral/iliac screw fixation system indicated for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, and previous failed fusion. when used in a percutaneous, posterior approach with avant spine mis instrumentation, this system is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients. when used for posterior non-cervical pedicle screw fixation in pediatric patients with autograft and/or allograft, the system implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. pediatric pedicle screw fixation is limited to a posterior approach. when used without osteopal? plus pmma bone cement or equivalent, this system?s fenestrated screws are intended for posterior, non-cervical pedicle fixation as an adjunct to fusion for the following indications: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion. when used in conjunction with osteopal? plus pmma bone cement or equivalent, this system?s fenestrated screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 61230 - metal-polymer composite spinal fusion cage - nuvasive interbody system are 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 and supplemental internalspinal fixation systems for use in the thoracolumbar spine. the systems are intended for use in interbody fusions in the thoracic spine, from t1 to t12, and at the thoracolumbar junction (t12-l1). the system implants are also intended for use in the lumbar spine, from l1 to s1, for the treatment of symptomatic disc disease or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation the interbody systems can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis. when used in the cervical spine, the interbody implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. the cervical interbody systems are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from c2-t1. the system is intended to be used with or without supplemental fixation. the system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 57805 - spinal fusion cage, non-sterile - nuvasive interbody system are 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 and supplemental internalspinal fixation systems for use in the thoracolumbar spine. the systems are intended for use in interbody fusions in the thoracic spine, from t1 to t12, and at the thoracolumbar junction (t12-l1). the system implants are also intended for use in the lumbar spine, from l1 to s1, for the treatment of symptomatic disc disease or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation the interbody systems can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis. when used in the cervical spine, the interbody implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. the cervical interbody systems are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from c2-t1. the system is intended to be used with or without supplemental fixation. the system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion.