Device Dossier

CoLink SFX Implant System - Fixation nail, intramedullary, arthrodesis

Device Dossier for CoLink SFX Implant System - Fixation nail, intramedullary, arthrodesis (Fixation nail, intramedullary, arthrodesis, Class IIb, sponsor…

Intended purpose

A sterile, single-use device for either short-term use (e.g., for use as a guide pin during implant insertion) or as an implant used for the temporary fixation and stabilisation of bone fractures and reconstructions of the extremities. It is designed to be removed after healing of the bone, around 3-6 months post-implantation.

TGA Public Summary