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FDA 510(k)

Active Intramedullary (AIM)胫骨钉系统

K号: K252025 · 2026-03-04

申请人Satori Orthopaedics, Inc.
决定日期2026-03-04
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

Active Intramedullary (AIM) Tibial Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Satori Orthopaedics, Inc.. It received FDA 510(k) clearance on 2026-03-04 under 510(k) number K252025. 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 Active Intramedullary (AIM) Tibial Nail System?

Active Intramedullary (AIM) Tibial Nail System is a medical device that received FDA 510(k) clearance on 2026-03-04. The listed applicant is Satori Orthopaedics, Inc.. The 510(k) number is K252025.

When did Active Intramedullary (AIM) Tibial Nail System receive FDA 510(k) clearance?

Active Intramedullary (AIM) Tibial Nail System received FDA 510(k) clearance on 2026-03-04, under 510(k) number K252025.

Who is the listed applicant for Active Intramedullary (AIM) Tibial Nail System?

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

What is the FDA product code for Active Intramedullary (AIM) Tibial Nail System?

The FDA product code for Active Intramedullary (AIM) Tibial Nail System 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

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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