Device Dossier

Orthopaedic bone screw, non-biodegradable, non-sterile

Device Dossier for Orthopaedic bone screw, non-biodegradable, non-sterile (Orthopaedic bone screw, non-biodegradable, non-sterile, Class IIb, sponsor…

Intended purpose

It is the manufacturer's intention that the screws be used for the fixing of bone plates to bone or for the fixation of fractures, fusions & osteotomies. The goal is to precisely position & maintain bony fragments in a desired orientation & to provide stable fixation of the osteotomy/fusion site until a stable bony union occurs.

TGA Public Summary