FDA 510(k)

Triathlon® 全膝关节系统 - Triathlon® Pro 后稳定（PS）股骨组件

K号: K230952 · 2023-06-02

申请人Howmedica Osteonics Corp., Dba Stryker Orthopaedics

决定日期2023-06-02

产品代码JWH

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

Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component 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 2023-06-02 under 510(k) number K230952. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component?

Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K230952.

When did Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component receive FDA 510(k) clearance?

Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component received FDA 510(k) clearance on 2023-06-02, under 510(k) number K230952.

Who is the listed applicant for Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component?

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 Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component?

The FDA product code for Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component is JWH.

列明Howmedica Osteonics Corp., Dba 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。

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官方来源

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