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

more group pty ltd - 62249 - custom-made anatomy model/surgical guide kit - custom made guides and biomodels manufactured by 3d printers intended to be used in surgical procedures, surgical treatment planning, anatomical visualisations, craniomaxillofacial surgical procedures and intraoperative procedures

Australia - engelsk - 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 - engelsk - 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 - engelsk - 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 - engelsk - 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.

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

stryker australia pty ltd - 62215 - custom-made anatomy model - anatomical bone model intended to be used by the surgeon as an anatomical reference in planning and performing the implantation of patient-fitted temporomandibular reconstruction prostheses

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

aa-med pty ltd - 62249 - custom-made anatomy model/surgical guide kit - cmf plastic guides and cmf orthognatic splints are intended to be used as surgical tools to transfer a preoperative plan to surgery. cmf plastic guides are intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. cmf orthognatic splints are intended to align the maxilla and/or mandible in orthognathic surgical procedures. the subject devices are intended for single use only.