Device Dossier

Orthopaedic bone staple, non-adjustable, sterile

Device Dossier for Orthopaedic bone staple, non-adjustable, sterile (Orthopaedic bone staple, non-adjustable, sterile, Class IIb, sponsor Advita Ortho…

Intended purpose

The devices are non-bioabsorbable, U-shaped implantable orthopaedic fixation staples made of metal alloy intended to be used for bone fixation to facilitate osteosynthesis. They are intended for bone reconstruction, fracture fixation, and fixation of soft tissue to bone. The devices are static, non-adjustable staples.

TGA Public Summary