FDA 510(k)

KLS Martin IPS 分离

K号: K220050 · 2022-08-11

决定日期2022-08-11

产品代码MQN

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决定实质等同

器械摘要

KLS Martin IPS Distraction 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 2022-08-11 under 510(k) number K220050. The device is classified under product code MQN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KLS Martin IPS Distraction?

KLS Martin IPS Distraction is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is KLS Martin L.P.. The 510(k) number is K220050.

When did KLS Martin IPS Distraction receive FDA 510(k) clearance?

KLS Martin IPS Distraction received FDA 510(k) clearance on 2022-08-11, under 510(k) number K220050.

Who is the listed applicant for KLS Martin IPS Distraction?

The FDA 510(k) record lists KLS Martin L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLS Martin IPS Distraction?

The FDA product code for KLS Martin IPS Distraction is MQN.

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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