Arthrex? UNIVERS? Glenoid Poly with Peg - Prosthesis, internal, joint, shoulder, glenoid component

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Prenos Javno poročilo o oceni (PAR)
27-05-2019

Dostopno od:

Arthrex Australia Pty Ltd

Razred:

Class III

Izdeluje:

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

Terapevtsko območje:

36259 - Prosthesis, internal, joint, shoulder, glenoid component

Terapevtske indikacije:

An artificial glenoid fossa made of polyethylene and attached to the scapula with combination curved keel and barbed cylindrical protrusions. The Arthrex UNIVERS Poly Glenoid with Peg is indicated in replacement(s) when conditions including severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.

Status dovoljenje:

A

Datum dovoljenje:

2018-08-30

Opozorila o iskanju, povezana s tem izdelkom