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