FDA 510(k)

MiRus 3DR 侧方腰椎椎间融合系统，带集成钢板固定

K号: K232154 · 2023-09-11

决定日期2023-09-11

产品代码OVD

咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。

决定实质等同

器械摘要

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2023-09-11 under 510(k) number K232154. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation?

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is a medical device that received FDA 510(k) clearance on 2023-09-11. The listed applicant is MiRus, LLC. The 510(k) number is K232154.

When did MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation receive FDA 510(k) clearance?

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation received FDA 510(k) clearance on 2023-09-11, under 510(k) number K232154.

Who is the listed applicant for MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation?

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

What is the FDA product code for MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation?

The FDA product code for MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is OVD.

列明MiRus, LLC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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