Device Dossier
Custom-made anatomy model
Device Dossier for Custom-made anatomy model (Custom-made anatomy model, Class IIa, sponsor Medacta). ARTG record, intended purpose, GMDN category —…
- GMDN category: Custom-made anatomy model
Intended purpose
Devices intended to be used intra-operatively to assist in the positioning of the MySolutions Patient- Matched Guides and in guiding the marking of bone according to the preoperative plan that the surgeon prepared in advance following the Medacta MySolutions process. The bone models are specific for a single patient anatomy and intended for single use only.