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 copy of a final spinal implantable device such as spinal cage etc. used to validate the proper size of the permanent device required by the patient and to determine its appropriate position and/or to verify that the site has been cut to the proper dimensions. This trial is reusable.