Arthrex? UNIVERS? Fracture Stem - Uncoated shoulder humeral stem prosthesis

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Arthrex Australia Pty Ltd

Klasse:

Class III

Fremstillet af:

Arthrex Inc 1370 Creekside Boulevard, Naples, Florida, 34108-1945 United States Of America

Terapeutisk område:

34197 - Uncoated shoulder humeral stem prosthesis

Terapeutiske indikationer:

A sterile base stem of the Univers II shoulder prosthesis placed in the proximal humerus having adjustable humeral head height for the management of fracture jigs and lateral fin positions with suture eyelets for anatomic reconstruction of the tuberosities. The Arthrex Univers? Fracture Stem Shoulder Humeral Prosthesis is indicated for severe pain or significant disability resulting from degenerative, rheumatoid, or traumatic disease or injury of the glenohumeral joint. This includes traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures, comminuted fracture, humeral head fracture, displaced 3- or 4- fragment proximal head fractures, avascular necrosis of the humeral head, and fractures of the anatomical neck. The Arthrex Univers? Shoulder Humeral Fracture Prosthesis is intended for cemented or non-cemented use. This device may be used for hemi or total shoulder repair.

Autorisation status:

A

Autorisation dato:

2018-08-30