FDA 510(k)

Rosa®膝关节系统

K号: K251314 · 2025-11-13

决定日期2025-11-13

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 2025-11-13 under 510(k) number K251314. 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 2025-11-13. The listed applicant is Orthosoft Inc. (d/b/a) Zimmer CAS. The 510(k) number is K251314.

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

Rosa® Knee System received FDA 510(k) clearance on 2025-11-13, under 510(k) number K251314.

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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