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 Symbios Orthopaedics).…

Intended purpose

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.

TGA Public Summary