Device Dossier

Fixation device, internal, nail, intramedullary, tibia

Device Dossier for Fixation device, internal, nail, intramedullary, tibia (Tibia intramedullary nail, Class IIb, sponsor Orthopediatrics AUS). ARTG…

Intended purpose

A rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, acts as an immobilization device to hold ends of a fractured bone in position. The device may also be used to support the bone in the presence of a pathological condition. The device may be a locked or unlocked model possessing a number of components to assist fixation of more proximal and distal conditions.

TGA Public Summary