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

zimmer biomet pty ltd - 46470 - orthopaedic implantation application software - computer software package used by the surgeon to view and template the position of implants onto a 3d image of the patients skeletal frame. the surgeon can change imlant size, orientation and see the effects this has on a rendered model of the patients skeletal frame. the surgeon can select preferences for cut depth, slope etc to show how these would affect the final implant position. typical applications include reviewing the orientation of acetabular cups, tibial and femoral knee components and partial knee components. the positioning data may be used to create a custom cutting guide.

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

johnson & johnson medical pty ltd t/a depuy synthes - 46470 - orthopaedic implantation application software - an individual software application program that adds specific computer-assisted display, processing, and/or analysis capabilities to a computer to simulate/evaluate implant placement and surgical treatment options. using ct and/or mri images, it can zoom, measure, and annotate 3d planned images in order to determine an appropriate surgical plan. the plan may be used to create a custom surgery guide.

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

mathys orthopaedics pty ltd - 46470 - orthopaedic implantation application software - a software application program that adds specific computer-assisted display, processing, and/or analysis capabilities to a computer to simulate/evaluate implant placement and surgical treatment options. using ct and/or mri images, it can zoom, measure, and annotate 3d planned images in order to determine an appropriate surgical plan. the plan may be used to create a custom surgery guide.

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

johnson & johnson medical pty ltd t/a depuy synthes - 46644 - craniofacial fixation plate kit, non-biodegradable - a pack that includes a combination of e.g. screws, custom made surgical guides, anatomical models or implants for bone reconstruction, augmentation and fixation in the craniofacial region eg craniofacial reconstruction, stabilise fractured bone, endobrow fixation, or craniotomy flap fixation.

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

emergo asia pacific pty ltd t/a emergo australia - 46470 - orthopaedic implantation application software - intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a ct scanner or a magnetic resonance imaging scanner. the device is also used as pre-operative software for simulating /evaluating implant placement and surgical treatment options.

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

aa-med pty ltd - 61689 - internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile - a pack that includes a combination of e.g. screws, plates, implants, surgical guides,and/or splints for bone repositioning, bone reconstruction, restoration of bonedefects, bone augmentation or fixation in the craniofacial region.

Australia - English - 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.

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

aa-med pty ltd - 46649 - orthopaedic fixation plate kit, non-biodegradable - cmf titanium guides, plates and implants are intended to transfer a preoperative plan to surgery. cmf titanium implants can be used in combination with a cmf titanium guides for predrilling the fixation screws. cmf titanium guides are intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. the cmf titanium plates can be used in combination with a cmf titanium guides for predrilling the fixation screws.

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

johnson & johnson medical pty ltd t/a depuy synthes - 58908 - cranial bone prosthesis, custom-made - intended for bone reconstruction and restoration of bone defects of the cranium or mandible.

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

johnson & johnson medical pty ltd t/a depuy synthes - 60826 - custom-made orthopaedic surgical guide, non-sterile - intended to guide the marking of bone and/or guide surgical instruments.