FDA 510(k)

KLS Martin 个体化患者解决方案 (IPS) 规划系统

K号: K182889 · 2019-07-26

决定日期2019-07-26

产品代码PPT

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决定实质等同

器械摘要

KLS Martin Individual Patient Solutions (IPS) Planning System is the device name listed in this FDA 510(k) record. The listed applicant is KLS-Martin L.P.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K182889. The device is classified under product code PPT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KLS Martin Individual Patient Solutions (IPS) Planning System?

KLS Martin Individual Patient Solutions (IPS) Planning System is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is KLS-Martin L.P.. The 510(k) number is K182889.

When did KLS Martin Individual Patient Solutions (IPS) Planning System receive FDA 510(k) clearance?

KLS Martin Individual Patient Solutions (IPS) Planning System received FDA 510(k) clearance on 2019-07-26, under 510(k) number K182889.

Who is the listed applicant for KLS Martin Individual Patient Solutions (IPS) Planning System?

FDA 510(k)记录中列出KLS-Martin L.P.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for KLS Martin Individual Patient Solutions (IPS) Planning System?

The FDA product code for KLS Martin Individual Patient Solutions (IPS) Planning System is PPT.

列明KLS-Martin L.P.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。

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 K254162KLS Martin Ixos 系统 K253660KLS Martin Pure Pectus 系统 K250988KLS Martin Pure Pectus 系统 K250865KLS Martin IPS 前臂系统 K252573KLS Martin 颅骨植入物 - MR 条件；K944565：KLS-Martin 微型骨合成系统（1.5MM）；K971297：KLS Martin 中心驱动无钻螺丝；K060177：KLS Martin 刚性固定 - 无菌；K062570：个体化患者解决方案 - Ti (IPS-Ti)；K072707：个体化患者解决方案 - PEEK (IPS-PEEK)；K151382：个体化患者解决方案 - (IPS-PEEK) - 无菌

查看所有 33 个设备 →

官方来源

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