FDA 510(k)

通用CMF系统

K号: K221855 · 2022-11-09

决定日期2022-11-09

产品代码JEY

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决定实质等同

器械摘要

Universal CMF System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2022-11-09 under 510(k) number K221855. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Universal CMF System?

Universal CMF System is a medical device that received FDA 510(k) clearance on 2022-11-09. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K221855.

When did Universal CMF System receive FDA 510(k) clearance?

Universal CMF System received FDA 510(k) clearance on 2022-11-09, under 510(k) number K221855.

Who is the listed applicant for Universal CMF System?

The FDA 510(k) record lists Stryker Leibinger GmbH & Co KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Universal CMF System?

The FDA product code for Universal CMF System is JEY.

列明Stryker Leibinger GmbH & Co KG为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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查看所有 19 个设备 →

相关器械（代码：JEY）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260137KLS Martin IPS 口腔-Max 种植体 - MR 条件性；个体化患者解决方案 - Ti (IPS-Ti)；个体化患者解决方案 - PEEK (IPS-PEEK)；KLS Martin 个体化患者解决方案KLS-Martin L.P.K253206细致入微的个性化CMF解决方案Meticuly Co., Ltd.K252246Leforte MMF 系统Jeil Medical Corporation K253373Southern 颅面 (CMF) 系统Southern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby生物可吸收固定系统；Inion CPS 1.5/2.0/2.5生物可吸收固定系统Inion OY K241314KLS Martin 口腔-Max 嵌入物 MR 条件性（捆绑）KLS-Martin L.P.

官方来源

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