Device Dossier

Craniofacial fixation plate kit, non-biodegradable

Device Dossier for Craniofacial fixation plate kit, non-biodegradable (Craniofacial fixation plate kit, non-biodegradable, Class IIb, sponsor Lyka…

Intended purpose

A collection of titanium plates and bone screws, of various shapes/sizes, that are implanted onto fractured craniofacial bone to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals. The device may also be used for craniofacial reconstructive procedures.

TGA Public Summary