FDA 510(k)

tmCMF解决方案

K号: K233874 · 2024-07-11

决定日期2024-07-11

产品代码JEY

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

tmCMF Solution is the device name listed in this FDA 510(k) record. The listed applicant is Techmah Cmf. It received FDA 510(k) clearance on 2024-07-11 under 510(k) number K233874. 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 tmCMF Solution?

tmCMF Solution is a medical device that received FDA 510(k) clearance on 2024-07-11. The listed applicant is Techmah Cmf. The 510(k) number is K233874.

When did tmCMF Solution receive FDA 510(k) clearance?

tmCMF Solution received FDA 510(k) clearance on 2024-07-11, under 510(k) number K233874.

Who is the listed applicant for tmCMF Solution?

The FDA 510(k) record lists Techmah Cmf as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for tmCMF Solution?

The FDA product code for tmCMF Solution is JEY.

列明Techmah Cmf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。

K231520tmCMF解决方案

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

在 FDA 数据库中查看 →

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。