Device Dossier

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Device Dossier for Orthopaedic fixation plate, non-bioabsorbable, non-sterile (Orthopaedic fixation plate, non-bioabsorbable, non-sterile, Class IIb,…

Intended purpose

An implantable plate that is used for the fixation of fractures or fracture dislocations, temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusions) or osteotomies. It is intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals. The device is non-sterile and made of non-bioabsorbable material. This device is intended to be sterilized prior to use.

TGA Public Summary