国械注进20153132392

辛迪思有限公司Synthes GmbH

Eimattstrasse 3, 4436 Oberdorf, Switzerland

Eimattstrasse 3, 4436 Oberdorf, Switzerland;Glutz Blotzheim-Str. 1 und 3,4500 Solothurn, Switzerland;Bohnackerweg 5, 2545 Selzach, Switzerland;Hauptstrasse 24, 4437 Waldenburg, Switzerland;Luzernstrasse 19, 4500 Solothurn, Switzerland;Muracherstrasse 3,2544 Bettlach, Switzerland;Solothurnstrasse 186, 2540 Grenchen, Switzerland;Im Bifang 6,4614 Hägendorf, 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 Umkirch b.Freiburg, Germany;Karolingerstr. 16, 5020 Salzburg, Austria;108 Willowbrook Lane, West Chester, 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

强生（上海）医疗器材有限公司

中国（上海）自由贸易试验区富特西一路439号第一、二、三层C部位

动力髋/动力髁螺钉DHS/DCS Screws

第三类

见附页

该产品由动力髋/动力髁螺钉、动力髋/动力髁加压螺钉和动力髋交锁装置组成，采用符合ISO5832-11的钛6铝7铌（TI Al6 Nb7）或符合ISO5832-1的不锈钢材料制造，钛合金表面经阳极氧化处理，产品一次性使用。包装分为灭菌包装和非灭菌包装，灭菌包装的产品采用GAMMA射线灭菌。

该产品与动力髋接骨板或动力髁接骨板配合，用于骨折内固定，协助完成骨折的复位，以重建解剖的复位，以重建解剖关系，并提供及时的稳定性。

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原注册证编号：国械注进20153462392

产品技术要求

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国家药品监督管理局

2020-04-24

2025-04-23

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