Австралія - англійська - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 43257 - fixation system, internal, spinal, bone screw - the nuvasive systems are intended to promote fusion of the cervical spine and occipito-thoracic junction (occiput-t3), and are indicated for degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture/dislocation, spinal stenosis, atlantoaxial fracture with instability, occipitocervical dislocation, spinal tumor, and/or revision of previous cervical spine surgery.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 46653 - spinal fixation plate, non-biodegradable - the nuvasive anterior cervical plate systems are intended for anterior screw fixation of the cervical spine. these implants have been designed to provide stabilisation as an adjunct to cervical fusion. indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis, or failed previous fusion.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 46653 - spinal fixation plate, non-biodegradable - the nuvasive anterior plate systems are indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (t1-l5) spine instability, or via the anterior surgical approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (l1-s1) spine instability, as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, and/or failed previous spine surgery.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 58473 - diagnostic digital imaging system workstation application software - 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.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 60741 - spinal rod bending system - the nuvasive bendini spinal rod bending system is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. a surgeon is able to use those instructions and bend a rod using the bendini spinal rod bender, a mechanical rod bender.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 64171 - vertebral body bone graft positioning plate - the halo buttress plate system is an anterior non-load bearing plate system that may be used in the thoracic, lumbar and sacral spine. the nuvasive halo buttress plate system, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 46653 - spinal fixation plate, non-biodegradable - a small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes. the device is typically used to provide immobilization and stabilisation of spinal segments in the treatment of various spinal instabilities or deformities.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 44052 - surgical procedure kit, orthopaedic, single-use, non-medicated - the sterile, single use instrument kits are designed for use in spinal surgery.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 57806 - vertebral body prosthesis, non-sterile - a non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. it is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. it is usually made of metal, polymer, or a combination of these materials. this device must be sterilized prior to use.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

nuvasive (aust/nz) pty ltd - 17751 - bone matrix implant, synthetic - attrax putty bone void filler consists of beta tcp and hydroxyapatite in a putty form. it induces and guides the three-dimensional regeneration of bone in the defect site into which it is implanted. when placed next to viable host bone, new bone will be deposited on the surface of attrax. it then resorbs and is replaced by bone during the natural process of bone remodelling. attrax putty bone void filler is intended for use as bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. attrax is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. attrax is intended to be packed into bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) and may be combined with autogenous bone, blood, prp, and/or bone marrow. attrax should not be used to treat large defects that in the surgeon?s opinion would fail to heal spontaneously. in load bearing situations, attrax is to b