Arthrex? ECLIPSE? Humeral Head TiNbN Coated - Humeral head prosthesis
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
सार्वजनिक आकलन रिपोर्ट
(PAR)
27-05-2019
अनुरोध भेजा।
थमां उपलब्ध:
Arthrex Australia Pty Ltd
वर्ग:
Class III
द्वारा बनाया गया:
Arthrex Inc 1370 Creekside Boulevard, Naples, Florida, 34108-1945 United States Of America
चिकित्सीय क्षेत्र:
48088 - Humeral head prosthesis
चिकित्सीय संकेत:
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.
प्राधिकरण का दर्जा:
A
प्राधिकरण की तारीख:
2018-08-30
