FDA 510(k)

MRI 通用

K号: K240651 · 2024-07-12

决定日期2024-07-12

产品代码JEY

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决定实质等同

器械摘要

MRI Universal 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 2024-07-12 under 510(k) number K240651. 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 MRI Universal?

MRI Universal is a medical device that received FDA 510(k) clearance on 2024-07-12. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K240651.

When did MRI Universal receive FDA 510(k) clearance?

MRI Universal received FDA 510(k) clearance on 2024-07-12, under 510(k) number K240651.

Who is the listed applicant for MRI Universal?

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 MRI Universal?

The FDA product code for MRI Universal 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。

K261054肋板系统 K254233MEDPOR 定制植入套件 K253623Spine Guidance 5.4 软件包；Spine Guidance 5.4 升级；Spine Guidance 5.4 更新；Spine Guidance 5.4 软件启用；Spine Guidance 5.4 销售演示；Q 钻孔跟踪器；NavLock 适配器；Elite Q 连接器；Elite 切割附件；Maestro Air 电机 K252871Spine Guidance 5.3 软件包；Q 内置体工具；Elite Q 连接器；Elite 切割附件 K243491胸骨钢板扩张器 K241517Q 导航系统；Mako 脊柱系统；

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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