Device Dossier

Spinal implant facsimile

Device Dossier for Spinal implant facsimile (Spinal implant facsimile, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN category —…

Intended purpose

A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) 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. It can be made of metal or plastic. This is a reusable device.

TGA Public Summary