Device Dossier

Internal Orthopaedic fixation system - Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Device Dossier for Internal Orthopaedic fixation system - Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile (Internal…

Intended purpose

The bone plate system is a plate and screw system made with titanium alloy ELI materials, included in the system are various plates and bone screws (Including locking and standard screws). The bone plate system are made of titanium alloy ELI material. Bone plate system is provided non-sterile for single use only. The bone plate system should be used by medical professionals and is intended for the fixation of fractures, osteotomies and nonunions of the humerus, ulna, radius, femur, tibia and fibula, particularly in osteopenic bone. The standard screw can be used separately and is intended for the fixation of fractures by interfragmentary compression.

TGA Public Summary