Device Dossier

Intraoperative bone pin/screw, sterile

Device Dossier for Intraoperative bone pin/screw, sterile (Intraoperative bone pin/screw, sterile, Class IIa, sponsor ACRA Regulatory Services). ARTG…

Intended purpose

Positioning and alignment device intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone or provide landmarks during navigated orthopaedic surgical procedures. Devices may be wholly- or partially-threaded for screwing into bone, and may have other physical features in various shapes and sizes to enable fixation of surgical instruments or facilitate navigation measurements. These are supplied as single-use sterile or single use non-sterile devices.

TGA Public Summary