Device Dossier
Orthopaedic bone screw (non-sliding)
Device Dossier for Orthopaedic bone screw (non-sliding) (Orthopaedic bone screw (non-sliding), Class IIb, sponsor Advita Ortho AUS). ARTG record,…
- GMDN category: Orthopaedic bone screw (non-sliding)
Intended purpose
The devices are small, threaded, non-bioabsorbable, implantable orthopaedic screws intended for internal fixation by being inserted into bone to provide fixation and stabilisation, either by securing orthopaedic implants such as plates and washers to bone or by providing direct interfragmentary stabilisation of fractured bone. The devices are of cortical or cancellous design and are intended to be inserted using a compatible surgical driver. They are intended for use in bone reconstruction, fracture fixation, arthrodesis, and osteotomy procedures of the foot and ankle.