FDA 510(k)

OrthoNext Platform System

K号: K242270 · 2024-12-19

决定日期2024-12-19

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

OrthoNext Platform System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K242270. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OrthoNext Platform System?

OrthoNext Platform System is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Orthofix Srl. The 510(k) number is K242270.

When did OrthoNext Platform System receive FDA 510(k) clearance?

OrthoNext Platform System received FDA 510(k) clearance on 2024-12-19, under 510(k) number K242270.

Who is the listed applicant for OrthoNext Platform System?

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

What is the FDA product code for OrthoNext Platform System?

The FDA product code for OrthoNext Platform System is QIH.

列明Orthofix Srl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。

K260146FITBONE® 运输和延长系统 K253991Fitbone™ 髋臼，FITBONE® 运输和延长系统，FITBONE® TAA K250112Fitbone™ 髋臼 K242861TrueLok 升级版 K233867Fitbone 髋臼 K232648RODEO伸缩钉

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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。