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…
- GMDN category: Tibia intramedullary nail
Intended purpose
A rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia to immobilize the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.