Device Dossier

Orthopaedic bur, single-use

Device Dossier for Orthopaedic bur, single-use (Orthopaedic bur, single-use, Class IIa, sponsor Ortho Solutions). ARTG record, intended purpose, GMDN…

Intended purpose

A sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g. orthopaedic). This is a single-use device. The OS products include but are not limited: OS STERILE BURRS

TGA Public Summary