Device Dossier
Orthopaedic implantation application software
Device Dossier for Orthopaedic implantation application software (Orthopaedic implantation application software, Class IIa, sponsor DePuy Synthes). ARTG…
- GMDN category: Orthopaedic implantation application software
Intended purpose
An individual software application program that adds specific computer-assisted display, processing, and/or analysis capabilities to a computer to simulate/evaluate implant placement and surgical treatment options. Using CT and/or MRI images, it can zoom, measure, and annotate 3D planned images in order to determine an appropriate surgical plan. The plan may be used to create a custom surgery guide.