Device Dossier

Custom-made anatomy model/surgical guide kit

Device Dossier for Custom-made anatomy model/surgical guide kit (Custom-made anatomy model/surgical guide kit, Class IIa, sponsor Materialise). ARTG…

Intended purpose

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.

TGA Public Summary