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颈椎前路钉板固定系统
| 产品名称： |
颈椎前路钉板固定系统Anterior Cervical Plate System |
| 注册/备案号： |
国械注进20163461614 |
| 注册/备案单位： |
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| 批准日期： |
2016.05.03 |
| 有效期： |
2021-05-02 |
| 变更日期： |
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| 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; Bohnackerweg 5, 2545 Selzach,Switzerland; Hauptstrasse 24, 4437 Waldenburg,Switzerland; Luzernstrasse 19-21,4528 Zuchwil,Switzerland; Solothurnstrasse 186, 2540 Grenchen,Switzerland; Muracherstrasse 3,2544 Bettlach,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; Karolingerstrasse 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
【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】该产品由接骨板和接骨螺钉组成。接骨板主体和接骨螺钉由符合ISO5832-11标准规定的Ti6Al7Nb钛合金材料制成，接骨板卡环由符合ISO5832-7标准规定的CoCrNiMoFe合金制成，防滑片由符合ISO5832-2标准规定4级纯钛制成。纯钛及钛合金产品表面经过了阳极化处理。非灭菌包装。
【适用范围】适用于颈椎(C2-C7节段)前路内固定。
【生产国或地区（中文）】瑞士
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医药数据
