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FDA 510(k)

股骨重建交锁钉系统，股骨逆行交锁钉系统，肱骨交锁钉系统，胫骨交锁钉系统，压缩髋关节钉系统

K号: K230071 · 2024-08-22

申请人Tdm Co., Ltd.
决定日期2024-08-22
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

Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Tdm Co., Ltd.. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K230071. 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 Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System?

Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Tdm Co., Ltd.. The 510(k) number is K230071.

When did Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System receive FDA 510(k) clearance?

Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System received FDA 510(k) clearance on 2024-08-22, under 510(k) number K230071.

Who is the listed applicant for Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System?

The FDA 510(k) record lists Tdm Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System?

The FDA product code for Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip 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

列明Tdm Co., Ltd.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。

K241128TDM 板和螺钉系统K240423TDM 前颈椎板系统K232115TDM 大骨板和螺钉系统K231860TDM 螺钉系统K221844TDM 腰椎椎间融合笼系统K220285PINE 椎弓根螺钉系统

查看所有 11 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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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