FDA 510(k)

Mako全髋关节应用 5.0

K号: K243751 · 2025-03-05

决定日期2025-03-05

产品代码OLO

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决定实质等同

器械摘要

Mako Total Hip Application 5.0 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 2025-03-05 under 510(k) number K243751. 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 Hip Application 5.0?

Mako Total Hip Application 5.0 is a medical device that received FDA 510(k) clearance on 2025-03-05. The listed applicant is Mako Surgical Corp.. The 510(k) number is K243751.

When did Mako Total Hip Application 5.0 receive FDA 510(k) clearance?

Mako Total Hip Application 5.0 received FDA 510(k) clearance on 2025-03-05, under 510(k) number K243751.

Who is the listed applicant for Mako Total Hip Application 5.0?

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 Hip Application 5.0?

The FDA product code for Mako Total Hip Application 5.0 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。

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官方来源

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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。