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

smith & nephew pty ltd - 13180 - orthopaedic prosthesis implantation instrument, reusable - surgical instruments used during navigation surgery to collect landmark points or to map the bone surface or to mark verification points on the bone or to attach array connectors to the bone and to aid in the implantation of an orthopaedic prosthesis.

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

rti surgical australia pty ltd - 13180 - orthopaedic prosthesis implantation instrument, reusable - a hand-held surgical instrument intended to be used during implantation of an orthopaedic device (e.g. plates, bone screws, rods, connectors), used manually to aid in the placement of the device or other instruments. it may be used to hold/align/fix bone preparation instruments, device, or device components; to provide relative position landmarks or spatial orientation; and/or as an interface between device components. this is a reusable device intended to be sterilized prior to use.

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

medacta australia pty ltd - 40808 - marker, lesion localization, implantable - tantalum markers are used to obtain distinct landmarks in the skeleton and implants during the research and evaluation method rsa (radiosterometric analysis). tantalum is metal with high atomic number facilitating identification on radiographs. it is biocompatible and resistant to corrosion. the tantalum markers are for single use only.

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

corin australia pty ltd - 40808 - marker, lesion localization, implantable - intended to be implanted into bone in order to create identifying marks that can be seen on film or digital images. the purpose of the tantalum markers is to insert the bead into the bone to get a distinct landmark in the bone. the tantalum markers are made of biocompatible spherical tantalum, a material that is well tolerated by the body and readily observed as a distinct point in the radiograph.

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

medtronic australasia pty ltd - 40808 - marker, lesion localization, implantable - the superlock? fiducial markers are biocompatible gold soft tissue markers implanted into the lungs to identify the location of normal or diseased tissue for future treatments. the marker is placed at or near the treatment site and can easily be visualized in subsequent imaging studies. the location of the treatment area is then identified with respect to the marker. to act as a radiologic landmark, to define the target position for a medical procedure. localization with a fiducial markers directly within or around lung tumours is considered an accurate way of aiding in gated radiation therapy because it directly marks the tumour position. the placement of fiducial markers within lung tumours can be achieved either transcutaneously or transbronchially through bronchoscopy-based approaches, such as the superdimension i?logic system.

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

rti surgical australia pty ltd - 58927 - orthopaedic prosthesis implantation instrument, single-use - a hand-held, manual surgical instrument intended for use during implantation of an orthopaedic prosthesis to aid in the placement of the prosthesis or other instruments. it may be used to hold/align/fix bone preparation instruments, prosthesis, or prosthesis components; and/or to provide relative position landmarks or spatial orientation. this is a single-use device.

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

zimmer biomet pty ltd - 38678 - robotic surgical system - the rosa? knee system is indicated as a stereotaxic instrumentation system for total knee replacement (tka) surgery. it is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. the robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan, optionally determined pre-operatively using compatible x-ray or mri based surgical planning tools. it includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.

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

zimmer biomet pty ltd - 13180 - orthopaedic prosthesis implantation instrument, reusable - a hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (cas) device, to aid in the navigation/placement of the prosthesis or other instruments. it may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. this is a reusable device intended to be sterilized prior to use.

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

orthotech pty ltd - 13180 - orthopaedic prosthesis implantation instrument, reusable - a hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis to aid in the navigation/placement of the prosthesis or other instruments. it may be used for; 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment

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

zimmer biomet pty ltd - 13180 - orthopaedic prosthesis implantation instrument, reusable - a hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (cas) device, to aid in the navigation/placement of the prosthesis or other instruments. it may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. this is a reusable device intended to be sterilized prior to use.