FDA 510(k)

CarboClear 导航工具

K号: K201251 · 2020-08-05

决定日期2020-08-05

产品代码OLO

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决定实质等同

器械摘要

CarboClear Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2020-08-05 under 510(k) number K201251. 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 CarboClear Navigated Instruments?

CarboClear Navigated Instruments is a medical device that received FDA 510(k) clearance on 2020-08-05. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K201251.

When did CarboClear Navigated Instruments receive FDA 510(k) clearance?

CarboClear Navigated Instruments received FDA 510(k) clearance on 2020-08-05, under 510(k) number K201251.

Who is the listed applicant for CarboClear Navigated Instruments?

The FDA 510(k) record lists CarboFix Orthopedics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CarboClear Navigated Instruments?

The FDA product code for CarboClear Navigated Instruments is OLO.

列明CarboFix Orthopedics , Ltd.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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