FDA 510(k)

Rosa膝关节系统

K号: K230180 · 2023-02-22

决定日期2023-02-22

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 2023-02-22 under 510(k) number K230180. 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 2023-02-22. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K230180.

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

Rosa Knee System received FDA 510(k) clearance on 2023-02-22, under 510(k) number K230180.

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。

K261510Signature™ ONE 系统 K260582ROSA® 肩关节系统 K260104Signature™ ONE 系统 K251314Rosa®膝关节系统 K242864ROSA® 膝关节系统 K233199ROSA® 肩关节系统

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