Arthrex? ECLIPSE? Humeral Head TiNbN Coated - Humeral head prosthesis

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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Download 공공 평가 보고서 (PAR)
27-05-2019

제공처:

Arthrex Australia Pty Ltd

수업:

Class III

Manufactured by:

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

치료 영역:

48088 - Humeral head prosthesis

치료 징후:

A coated sterile artificial humeral head designed to be attached to an Eclipse Trunion humeral stem prosthesis and to articulate against an artificial or natural glenoid fossa. The Arthrex ECLIPSE? Humeral Head Shoulder Prosthesis is indicated as a total or hemi shoulder joint replacement where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or re-constructible for the following specific indications: - Degenerative pathologies: osteoarthritis, arthritis due to instability, and idiopathic avascular humeral head necrosis. - Post-traumatic pathologies: post-traumatic arthritis, post-traumatic instability, and post-traumatic humeral head necrosis. It is intended for non-cemented use only.

승인 상태:

A

승인 날짜:

2018-08-30

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