FDA 510(k)

CORUS-LX 移植物

K号: K253190 · 2025-11-20

决定日期2025-11-20

产品代码MRW

决定实质等同

器械摘要

CORUS-LX Implant is the device name listed in this FDA 510(k) record. The listed applicant is Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K253190. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

常见问题

What is the CORUS-LX Implant?

CORUS-LX Implant is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K253190.

When did CORUS-LX Implant receive FDA 510(k) clearance?

CORUS-LX Implant received FDA 510(k) clearance on 2025-11-20, under 510(k) number K253190.

Who is the listed applicant for CORUS-LX Implant?

The FDA 510(k) record lists Providence Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORUS-LX Implant?

The FDA product code for CORUS-LX Implant is MRW.

列明Providence Medical Technology, Inc.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。

K261665CORUS® 导航系统-GN K253676CORUS® 后颈椎稳定系统 3D (CORUS® PCSS 3D)K251060CORUS® 导航系统-GX K251885CAVUX 骨突固定系统（CAVUX FFS）和 CORUS-LX 移植 K241035PMT 后颈椎稳定系统（PCSS）K240625CORUS 导航访问系统

查看所有 19 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。