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FDA 510(k)

Fitbone™ 髋臼，FITBONE® 运输和延长系统，FITBONE® TAA

K号: K253991 · 2026-05-08

申请人Orthofix Srl
决定日期2026-05-08
产品代码HSB
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

Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K253991. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA?

Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Orthofix Srl. The 510(k) number is K253991.

When did Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA receive FDA 510(k) clearance?

Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA received FDA 510(k) clearance on 2026-05-08, under 510(k) number K253991.

Who is the listed applicant for Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA?

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

What is the FDA product code for Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA?

The FDA product code for Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA is HSB.

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Orthofix Srl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。

K260146FITBONE® 运输和延长系统K250112Fitbone™ 髋臼K242270OrthoNext Platform SystemK242861TrueLok 升级版K233867Fitbone 髋臼K232648RODEO伸缩钉

查看所有 24 个设备 →

相关器械（代码：HSB）

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。

K261345儿童接骨平台 股骨OrthoPediatrics Corp.K261481Pangea股骨重建系统Stryker GmbHK253080AND 医疗股骨钉系统（PFNA01）；AND 医疗股骨钉系统（PFNA02）Suzhou and Science & Technology Development Corp.K261651Precice® Max System and Precice® Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155富乐金属锁定髓内钉系统Beijing Fule Science & Technology Development Co., Ltd.K253046HERA 齿锁髓内钉系统ZheJiang Decans Medical Devices Co., Ltd.

官方来源

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