Medacta Shoulder System Double Eccenter - Shoulder humeral body prosthesis

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

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download PAR (PAR)
19-07-2023

MAH:

Medacta Australia Pty Ltd

class:

Class III

manufactured_by:

Medacta International SA Strada Regina 6874 Castel, San Pietro Switzerland

therapeutic_area:

60512 - Shoulder humeral body prosthesis

therapeutic_indication:

An eccentric tapered connector that is connected to the Anatomic Metaphysis by means of a press-fit cylinder. The Humeral Head is then coupled to the Double Eccenter by means of an eccentric Morse taper connection. The Anatomic Medacta Shoulder System is intended for use as a hemi or total shoulder replacement. It is a single-use device for the reconstruction of the gleno-humeral joint in case of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis as well as complex fractures, post-traumatic malunion and revision of failed arthroplasty in patients with an intact or reparable rotator cuff shoulder joint. The humeral components are for cemented and cementless use.

authorization_status:

A

authorization_date:

2022-12-09