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

osseointegration holdings pty ltd - 62249 - custom-made anatomy model/surgical guide kit - guides and biomodels manufactured by 3-d printing intended to assist in anatomical visualization, surgical treatment planning, for intraoperative dental and craniomaxillofacial surgical procedures

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

osseointegration holdings pty ltd - 60826 - custom-made orthopaedic surgical guide, non-sterile - the patient specific surgical guide (pssg) is a medical device designed to assist in the intraoperative orientation of implant components or indication of the required cut/drill lines to achieve a pre-determined osteotomy geometry. the intended function of the pssg includes physical interfacing with bone geometry for placement, outlining the desired cut-line, and/or guiding of surgical instruments (e.g. surgical drill, oscillating cutting saw). the pssg is indicated to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) where the attending physician requires additional guidance in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw).

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

aa-med pty ltd - 62215 - custom-made anatomy model - a non-sterile orthopaedic biomodel designed to represent a specific patient intended to be used as surgical tools to transfer a pre-operative plan to surgery.

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

aa-med pty ltd - 62215 - custom-made anatomy model - a non-sterile craniofacial biomodel designed to represent a specific patient intended to be used as surgical tools to transfer a pre-operative plan to surgery.

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

dental smile designers atf the bright smiles laboratory trust - 62249 - custom-made anatomy model/surgical guide kit - the dsd surgical guide is intended to assist in anatomical visualization for intraoperative dental and craniomaxillofacial surgical procedures.

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

zimmer biomet pty ltd - 62215 - custom-made anatomy model - a model of the bone of a specific patient intended for use to facilitate accurate preoperative planning and introperative placement of a device during orthopaedic surgical procedures.

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

symbios orthopaedics pty ltd - 62249 - custom-made anatomy model/surgical guide kit - a set of single use instruments intended to be used in an orthopaedic procedure. it includes patient specific cutting guides to assist in the intraoperative orientation of implant components and other relevant disposable instruments relevant to the positioning of the cutting guides and also may contain relevant bone models. the devices are supplied sterile in a single box.

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

the australian centre for complex integrated surgical solutions - 62215 - custom-made anatomy model - the patient matched anatomical model is a model (physical and/or virtual) of an organ (e.g., heart, kidney, lung), bone or other anatomical feature of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. the physical model is created using additive (three-dimensional [3-d] printing) processes based on patient medical images which have been segmented and transformed into virtual anatomical models. the physical model is typically made of a synthetic polymer, marked with a unique identifier, and may be sterilized prior to use in sterile fields when produced and provided as sterilisable.

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

precision ai pty ltd - 60826 - custom-made orthopaedic surgical guide, non-sterile - the precision ai surgical guides are patient specific guides (or instruments) intended to assist surgeons with the task of accurately recreating the pre-operative plan in orthopaedic surgeries.

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

queensland health - metro north hospital and health service - 62215 - custom-made anatomy model - the patient matched anatomical model is intended to be used in the planning of clinical procedures to assist anatomic visualization, case education, and/or surgical treatment planning. the device is intended to be used by a trained medical professional who is familiar with the specific patient case. the device is intended for the particular case as identified by the requesting medical professional.