Device Dossier

External Fixation System - Fixation device, external, system

Device Dossier for External Fixation System - Fixation device, external, system (Fixation device, external, system, Class IIb, sponsor Life Healthcare).…

Intended purpose

The Orthofix External Fixation consists of a series of monolateral or circular external fixators intended to be used in conjunction with Orthofix Bone Screws, threaded wires or Kirschner wires and the Fragment Fixation System and relevant instrumentation. These devices are intended as a means to stabilize bone segments in a broad range of indications, including fractures, joint fusion, bone transport, lengthening and angular corrections.

TGA Public Summary