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FDA 510(k)

Tornier肱骨重建系统（Tornier HRS）；Tornier Perform肱骨系统 - 股骨柄（Tornier PHS-Stem）

K号: K241878 · 2024-12-06

申请人Stryker Corporation (Tornier, Inc.)
决定日期2024-12-06
产品代码KWS
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

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation (Tornier, Inc.). It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K241878. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)?

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Stryker Corporation (Tornier, Inc.). The 510(k) number is K241878.

When did Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) receive FDA 510(k) clearance?

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) received FDA 510(k) clearance on 2024-12-06, under 510(k) number K241878.

Who is the listed applicant for Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)?

The FDA 510(k) record lists Stryker Corporation (Tornier, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)?

The FDA product code for Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) is KWS.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Stryker Corporation (Tornier, Inc.)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。

K260102Tornier Perform 反向鹅颈和Tornier Perform 反向增强鹅颈肩关节系统K241609托尼尔肱骨重建系统（Tornier HRS）

相关器械（代码：KWS）

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。

K260721托尼尔高性能肩胛窝Tornier, Inc.K254084AETOS ǽ - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x肩关节系统Catalyst Orthoscience, Inc.K252416AETOS ǽ Meta ʽSmith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241609托尼尔肱骨重建系统（Tornier HRS）Stryker Corporation (Tornier, Inc.)

官方来源

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