FDA 510(k)

OptiVu™ ROSA® MxR

K号: K230567 · 2023-06-13

决定日期2023-06-13

产品代码SBF

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决定实质等同

器械摘要

OptiVu™ ROSA® MxR 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 2023-06-13 under 510(k) number K230567. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OptiVu™ ROSA® MxR?

OptiVu™ ROSA® MxR is a medical device that received FDA 510(k) clearance on 2023-06-13. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K230567.

When did OptiVu™ ROSA® MxR receive FDA 510(k) clearance?

OptiVu™ ROSA® MxR received FDA 510(k) clearance on 2023-06-13, under 510(k) number K230567.

Who is the listed applicant for OptiVu™ ROSA® MxR?

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 OptiVu™ ROSA® MxR?

The FDA product code for OptiVu™ ROSA® MxR is SBF.

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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