FDA 510(k)

EZ-TRAX Stryker Mako 全膝关节置换术与Triathlon 隔离装置

K号: K202270 · 2020-12-02

决定日期2020-12-02

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device is the device name listed in this FDA 510(k) record. The listed applicant is K1 Medical, LLC. It received FDA 510(k) clearance on 2020-12-02 under 510(k) number K202270. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device?

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device is a medical device that received FDA 510(k) clearance on 2020-12-02. The listed applicant is K1 Medical, LLC. The 510(k) number is K202270.

When did EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device receive FDA 510(k) clearance?

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device received FDA 510(k) clearance on 2020-12-02, under 510(k) number K202270.

Who is the listed applicant for EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device?

The FDA 510(k) record lists K1 Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device?

The FDA product code for EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device is KCT.

列明K1 Medical, LLC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。

K213209EZ-TRAX Zimmer G7 髋臼系统 / Taperloc 完整髋关节系统隔离装置 K211007EZ-TRAXTM Persona 膝关节隔离装置 K192487EZ-TRAX 隔离装置

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。