FDA 510(k)

ROSA® 膝关节系统

K号: K213708 · 2022-04-22

决定日期2022-04-22

产品代码OLO

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决定实质等同

器械摘要

ROSA® Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K213708. 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 ROSA® Knee System?

ROSA® Knee System is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K213708.

When did ROSA® Knee System receive FDA 510(k) clearance?

ROSA® Knee System received FDA 510(k) clearance on 2022-04-22, under 510(k) number K213708.

Who is the listed applicant for ROSA® Knee System?

The FDA 510(k) record lists Orthosoft Inc (D/B/A Zimmer Cas) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROSA® Knee System?

The FDA product code for ROSA® Knee System is OLO.

列明Orthosoft Inc (D/B/A Zimmer Cas)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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