Device Dossier
Spinal implant facsimile
Device Dossier for Spinal implant facsimile (Spinal implant facsimile, Class IIa, sponsor DePuy Synthes). ARTG record, intended purpose, GMDN category —…
- GMDN category: Spinal implant facsimile
Intended purpose
A re-usable copy of a final spinal prosthesis, graft, or other implantable device used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions.