脊柱内固定系统

产品名称： 脊柱内固定系统Matrix 5.5 Spine System 注册/备案号： 国械注进20163461903 注册/备案单位： 批准日期： 2016.05.16 有效期： 2021-05-15 变更日期： 产品介绍： 【注册人名称】Synthes GmbH 【注册人住所】Eimattstrasse 3, 4436 Oberdorf, Switzerland 【生产地址】Eimattstrasse 3,4436 Oberdorf,Switzerland Glutz Blotzheim-Str. 1 und 3,4500Solothurn, Switzerland Bohnackerweg 5, 2545Selzach, Switzerland Hauptstrasse 24, 4437Waldenburg, Switzerland Luzernstrasse 19, 4500Solothurn, Switzerland Muracherstrasse 3,2544Bettlach, Switzerland Solothurnstrasse 186, 2540Grenchen, Switzerland Im Bifang 6,4614 Haegendorf,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 【代理人名称】强生(上海)医疗器材有限公司 【型号、规格】见附页 【结构及组成】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。 【适用范围】该产品用于胸腰椎和腰骶椎后路内固定。 【生产国或地区（中文）】瑞士