Device Dossier
Custom-made anatomy model
Device Dossier for Custom-made anatomy model (Custom-made anatomy model, Class IIa, sponsor DePuy Synthes). ARTG record, intended purpose, GMDN category…
- GMDN category: Custom-made anatomy model
Intended purpose
A model of an organ or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images.