Device Dossier
Spinal implant facsimile
Device Dossier for Spinal implant facsimile (Spinal implant facsimile, Class IIa, sponsor ACRA Regulatory Services). ARTG record, intended purpose, GMDN…
- GMDN category: Spinal implant facsimile
Intended purpose
Copy of a spinal interbody fusion prosthesis, 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.