FDA 510(k)

T2 Alpha胫骨内固定系统，T2 Alpha股骨前路固定GT/PF内固定系统，IMN螺钉系统，IMN工具系统

K号: K180436 · 2018-06-06

决定日期2018-06-06

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

T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Trauma GmbH. It received FDA 510(k) clearance on 2018-06-06 under 510(k) number K180436. 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 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System?

T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System is a medical device that received FDA 510(k) clearance on 2018-06-06. The listed applicant is Stryker Trauma GmbH. The 510(k) number is K180436.

When did T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System receive FDA 510(k) clearance?

T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System received FDA 510(k) clearance on 2018-06-06, under 510(k) number K180436.

Who is the listed applicant for T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System?

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

What is the FDA product code for T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System?

The FDA product code for T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System is HSB.

列明Stryker Trauma GmbH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。

K200869伽马3系统 K193308T2 Alpha胫骨内固定系统，IMN螺钉系统 K191271T2 Alpha股骨前路固定GT/PF内固定系统，T2 Alpha胫骨内固定系统，IMN螺钉系统，IMN工具系统 K172774T2 Alpha股骨前路固定GT/PF内固定系统，IMN螺钉系统，IMN工具系统 K170418Stryker SonicPin系统

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。