Device Dossier

Surgical procedure kit, orthopaedic, reusable

Device Dossier for Surgical procedure kit, orthopaedic, reusable (Surgical procedure kit, orthopaedic, reusable, Class IIa, sponsor Enovis Surgical).…

Intended purpose

Intended to be used for the implant of an anatomic shoulder prosthesis for total primary shoulder joint replacement in patients suffering from disability due to non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; and inflammatory degenerative joint disease such as rheumatoid arthritis; treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods.

TGA Public Summary