FDA 510(k)

Stryker CMF MEDPOR 优先定制植入物套装

K号: K191916 · 2019-08-15

决定日期2019-08-15

产品代码FWP

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决定实质等同

器械摘要

Stryker CMF MEDPOR Priority Customized Implant Kit 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 2019-08-15 under 510(k) number K191916. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Stryker CMF MEDPOR Priority Customized Implant Kit?

Stryker CMF MEDPOR Priority Customized Implant Kit is a medical device that received FDA 510(k) clearance on 2019-08-15. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K191916.

When did Stryker CMF MEDPOR Priority Customized Implant Kit receive FDA 510(k) clearance?

Stryker CMF MEDPOR Priority Customized Implant Kit received FDA 510(k) clearance on 2019-08-15, under 510(k) number K191916.

Who is the listed applicant for Stryker CMF MEDPOR Priority Customized Implant Kit?

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 Stryker CMF MEDPOR Priority Customized Implant Kit?

The FDA product code for Stryker CMF MEDPOR Priority Customized Implant Kit is FWP.

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 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。