国食药监械(进)字2012第3463344号(更)

Synthes GmbH

Eimattstrasse 3, 4436 Oberdorf, Switzerland

Eimattstrasse 3,4436 Oberdorf,Switzerland； Glutz Blotzheim-Str. 1 und 3,4500Solothurn, Switzerland；Bohnackerweg 5, 2545Selzach, Switzerland；Hauptstrasse 24, 4437Waldenburg, Switzerland；Luzernstrasse 19, 4500Solothurn, SwitzerlandMuracherstrasse 3,2544Bettlach, Switzerland；Solothurnstrasse 186, 2540Grenchen, Switzerland；Im Bifang 6,4614 Hagendorf,Switzerland；Zona Industriale 4,6805 Mezzovico,Switzerland；Stabile Morina, 6805 Mezzovico,Switzerland；Kanalstrasse West 30, 3942 Raron,Switzerland；Dornacherstrasse 20, 4710 Balsthal,Switzerland；Im Kirchenhürstle 4-6, 79224 Umkirchb.Freiburg, Germany；Karolingerstr. 16, 5020Salzburg, Austria；108 Willowbrook Lane, WestChester, PA 19382, USA；1302 Wrights Lane East,West Chester, PA 19380, USA；1303 Goshen Parkway,West Chester, PA 19380, USA；1301 Goshen Parkway,West Chester, PA 19380, USA；1230 Wilson Drive,West Chester, PA 19380, USA；1690 Russell Road,Paoli, PA 19301, USA；1051 Synthes Avenue,Monument, CO 80132, USA；35 Airport Road,Horseheads, NY 14845, USA；6244 Ferris Square,Suite B, San Diego, CA 92121, USA。

辛迪思(上海)医疗器械贸易有限公司

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脊柱内固定系统(商品名：Matrix 5.5) Matrix 5.5 Spine System

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见附页

该系统由椎弓根螺钉、钩、锁定螺帽/头、杆、杆连接器组成。椎弓根螺钉、钩、锁定螺帽/头和杆连接器由符合ISO5832-11的Ti6Al7Nb材料制成，杆由符合ISO5832-2的4级纯钛材料、符合ISO5832-11的Ti6Al7Nb材料和符合YY0605.12的钴铬钼合金材料制成;钛和钛合金产品表面经阳极化着色处理;产品为非灭菌包装。

该产品用于胸腰椎和腰骶椎后路内固定。

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代理人由“辛迪思(上海)医疗器械贸易有限公司”变更为“强生(上海)医疗器材有限公司”；售后服务机构由“辛迪思(上海)医疗器械贸易有限公司”变更为“辛迪思(上海)医疗器械贸易有限公司”和“强生(上海)医疗器材有限公司”；注册证由“国食药监械(进)字2012第3463344号”变更为“国食药监械(进)字2012第3463344号(更)”,原证自发证之日起作废。

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2012.09.13

2016.09.12

2013.02.28变更