Device Dossier

Orthopaedic implantation application software

Device Dossier for Orthopaedic implantation application software (Orthopaedic implantation application software, Class IIa, sponsor Materialise). ARTG…

Intended purpose

The device is indicated for use when a suitably licensed and qualified healthcare professional requires access to medical images with the intention of using such images to plan or review a surgical procedure. The device provides a set of tools and templates (representing prosthetic and fixation devices) to assist the healthcare professional in planning their surgery. The device is not to be used for mammography.

TGA Public Summary