Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

signature orthopaedics pty ltd - 59688 - femoral head/stem prosthesis adaptor - the evolve sleeve connects the unipolar head to the stem via matching tapers, as part of a partial hip joint replacement. the device is manufactured from cocr alloy and has a 12/14 taper. the evolve taper sleeve is intended to connect the unipolar head to the stem as part of a partial hip joint replacement. the device is indicated for: ? non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis ? inflammatory joint disease including rheumatoid arthritis ? correction of functional deformity including congenital hip dysplasia ? traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture ? failed previous hip surgery including internal fixation or joint fusion,reconstruction, hemiarthroplasty, surface replacement.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

signature orthopaedics pty ltd - 44362 - constrained polyethylene acetabular liner - the logical constrained liner connects to an acetabular shell and provides an articular surface for a femoral head as part of a total hip joint replacement. the device includes a mechanism for retaining the femoral head within the liner to prevent dislocation. the device is manufactured from cross-linked polyethylene and incorporates a snap-ring manufactured from ti6al4v alloy. the logical constrained xlpe acetabular liner is intended to be used in hip joint replacement where bone stock is sufficient to support the implant. when a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: -non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis -inflammatory joint disease including rheumatoid arthritis (excluding tsi stem) -correction of functional deformity including congenital hip dysplasia -traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture -failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement signature orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

signature orthopaedics pty ltd - 43167 - acetabular shell - the logical g-series cup shell is intended to connect a liner to the patient's acetabulum as part of a total hip joint replacement, where bone stock is sufficient to support the implant. when a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: ?non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis ?inflammatory joint disease including rheumatoid arthritis (excluding tsi stem) ?correction of functional deformity including congenital hip dysplasia ?traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture ?failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

signature orthopaedics pty ltd - 43168 - non-constrained polyethylene acetabular liner - the logical xlpe liners are intended for use with signature orthopaedics hip replacement range to replace a hip joint where bone stock is sufficient to support the implant. when a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: -non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis -inflammatory joint disease including rheumatoid arthritis -correction of functional deformity including congenital hip dysplasia -traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture -failed previous hip surgery including internal fixation or joint fusion,reconstruction, hemiarthroplasty, surface replacement, or total replacement

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

maxoniq pty ltd - 36042 - prosthesis, internal, joint, temporomandibular, total - the omx tmj total joint replacement system is intended to be used for the reconstruction of the temporomandibular joint(s). the system consists of a stock mandibular ramus metal alloy condyle, stock polymer based glenoid fossa component, fixation screws and drill bits, and a driver blade and handle.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 48091 - reverse shoulder prosthesis base plate - a component of the tornier perform reversed augmented glenoid system intended to be attached to the scapula to serve as the foundation of the glenosphere. made of titanium alloy. the backside of the baseplate has a porous structure and the topside is solid. the center post of the baseplate accommodates a central screw for primary fixation and up to four peripheral screws for additional stability. the baseplate comes in different augment wedge angles to accommodate glenoid bone loss. a component of the tornier perform reversed augmented glenoid system intended for replacement of the glenoid part of the scapulohumeral joint as part of a reverse shoulder prosthesis. the system is intended to reduce pain and improve shoulder mobility, in comparison with preoperative status, in patients with a functional deltoid muscle and with a massive and non-repairable rotator cuff-tear.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 48091 - reverse shoulder prosthesis base plate - a component of the toriner perform reversed system intended to be attached to the scapula to serve as the foundation of the glenosphere. the baseplate is made of a single piece of titanium alloy. the backside of the baseplate has a porous structure and the topside of the baseplate is solid. the center post of the baseplate accommodates a central screw or a press-fit post for primary fixation to the bone, and up to four peripheral screws for additional stability. a component of the tornier perform reversed glenoid system intended for replacement of the glenoid part of the scapulohumeral joint as part of a reverse shoulder prosthesis. the system is intended to reduce pain and improve shoulder mobility, in comparison with preoperative status, in patients with a functional deltoid muscle and with a massive and non-repairable rotator cuff-tear.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 48093 - reverse shoulder prosthesis head - a hemispherical component of the tornier perform reversed glenoid system intended to be attached to the baseplate to articulate with a congruent reverse shoulder insert. the glenosphere is made of cobalt chromium alloy and contains a morse taper connection that mates with a taper on the baseplate components. it also includes assembled subcomponents that make up a captured locking screw used as secondary locking mechanism to lock the glenosphere onto the baseplate in addition to the taper. a component of the tornier perform reversed glenoid system intended for replacement of the glenoid part of the scapulohumeral joint as part of a reverse shoulder prosthesis. the system is intended to reduce pain and improve shoulder mobility, in comparison with preoperative status, in patients with a functional deltoid muscle and with a massive and non-repairable rotator cuff-tear.

Jihoafrická republika - angličtina - South African Health Products Regulatory Authority (SAHPRA)

ferring (pty) ltd - injection - see ingredients - each syringe contains triptorelin acetate equivalent to triptorelin 3,75 mg

Jihoafrická republika - angličtina - South African Health Products Regulatory Authority (SAHPRA)

ferring (pty) ltd - injection - see ingredients - each 1,0 ml suspension contains dextran 70 104,0 mg