FDA 510(k)

Restoration®模块化髋关节系统

K号: K193233 · 2020-05-27

申请人Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)

决定日期2020-05-27

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

Restoration® Modular Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). It received FDA 510(k) clearance on 2020-05-27 under 510(k) number K193233. 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 Restoration® Modular Hip System?

Restoration® Modular Hip System is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). The 510(k) number is K193233.

When did Restoration® Modular Hip System receive FDA 510(k) clearance?

Restoration® Modular Hip System received FDA 510(k) clearance on 2020-05-27, under 510(k) number K193233.

Who is the listed applicant for Restoration® Modular Hip System?

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

What is the FDA product code for Restoration® Modular Hip System?

The FDA product code for Restoration® Modular Hip System is LPH.

列明Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)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。

K190991铁人三项三联钛中股骨锥形增强器，铁人三项股骨远端增强器

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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官方来源

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