FDA 510(k)

Mako全膝关节应用

K号: K241011 · 2024-06-11

决定日期2024-06-11

产品代码OLO

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Mako Total Knee Application is the device name listed in this FDA 510(k) record. The listed applicant is Mako Surgical Corp.. It received FDA 510(k) clearance on 2024-06-11 under 510(k) number K241011. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Mako Total Knee Application?

Mako Total Knee Application is a medical device that received FDA 510(k) clearance on 2024-06-11. The listed applicant is Mako Surgical Corp.. The 510(k) number is K241011.

When did Mako Total Knee Application receive FDA 510(k) clearance?

Mako Total Knee Application received FDA 510(k) clearance on 2024-06-11, under 510(k) number K241011.

Who is the listed applicant for Mako Total Knee Application?

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

What is the FDA product code for Mako Total Knee Application?

The FDA product code for Mako Total Knee Application is OLO.

列明Mako Surgical Corp.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。

K260222Mako全膝关节应用 K250608Mako全膝关节应用（3.0）；混合尖端指示器 K243751Mako全髋关节应用 5.0 K242373Mako肩关节应用（1.0）K220930Restoris 多隔室膝关节系统 K220459Mako全膝关节应用

查看所有 16 个设备 →

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。