FDA 510(k)

Achieve部分膝关节系统 - 多孔涂层的钴铬钼股骨组件

K号: K251975 · 2025-09-02

决定日期2025-09-02

产品代码NJD

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

Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component is the device name listed in this FDA 510(k) record. The listed applicant is Ignite Orthomotion. It received FDA 510(k) clearance on 2025-09-02 under 510(k) number K251975. The device is classified under product code NJD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component?

Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component is a medical device that received FDA 510(k) clearance on 2025-09-02. The listed applicant is Ignite Orthomotion. The 510(k) number is K251975.

When did Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component receive FDA 510(k) clearance?

Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component received FDA 510(k) clearance on 2025-09-02, under 510(k) number K251975.

Who is the listed applicant for Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component?

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

What is the FDA product code for Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component?

The FDA product code for Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component is NJD.

列明Ignite Orthomotion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。

K242307ACHIEVE 部分膝关节系统

官方来源

在 FDA 数据库中查看 →

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。