Device Dossier

Orthopaedic bone screw (non-sliding)

Device Dossier for Orthopaedic bone screw (non-sliding) (Orthopaedic bone screw (non-sliding), Class IIb, sponsor Compliance Management Solutions). ARTG…

Intended purpose

These devices are intended to be used for fixation of tissue to bone, including ligament or tendon to bone, or a bone to bone. They can also use as stand-alone bone screws, or in a plate screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the long bones & small bones. These devices are also intended to provide soft tissue reattachment (i.e. fixation of ligament and tendon graft tissue). These devices may be used in either arthroscopic or open surgical procedures

TGA Public Summary