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FDA 510(k)

Stryker 和 Serf 髋关节设备

K号: K250989 · 2025-07-25

决定日期2025-07-25
产品代码LPH
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

Stryker and Serf hip devices is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp (Dba Stryker Orthopaedics). It received FDA 510(k) clearance on 2025-07-25 under 510(k) number K250989. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Stryker and Serf hip devices?

Stryker and Serf hip devices is a medical device that received FDA 510(k) clearance on 2025-07-25. The listed applicant is Howmedica Osteonics Corp (Dba Stryker Orthopaedics). The 510(k) number is K250989.

When did Stryker and Serf hip devices receive FDA 510(k) clearance?

Stryker and Serf hip devices received FDA 510(k) clearance on 2025-07-25, under 510(k) number K250989.

Who is the listed applicant for Stryker and Serf hip devices?

The FDA 510(k) record lists Howmedica Osteonics Corp (Dba Stryker Orthopaedics) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stryker and Serf hip devices?

The FDA product code for Stryker and Serf hip devices is LPH.

相关临床试验

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。

列明Howmedica Osteonics Corp (Dba Stryker Orthopaedics)为申报人的其他记录

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查看所有 27 个设备 →

相关器械(代码:LPH)

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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