FDA 510(k)

Treace医疗系统（TMC）板层系统

K号: K240173 · 2024-02-22

决定日期2024-02-22

产品代码HRS

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

Treace Medical Systems (TMC) Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical Concepts, Inc.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K240173. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Treace Medical Systems (TMC) Plating System?

Treace Medical Systems (TMC) Plating System is a medical device that received FDA 510(k) clearance on 2024-02-22. The listed applicant is Treace Medical Concepts, Inc.. The 510(k) number is K240173.

When did Treace Medical Systems (TMC) Plating System receive FDA 510(k) clearance?

Treace Medical Systems (TMC) Plating System received FDA 510(k) clearance on 2024-02-22, under 510(k) number K240173.

Who is the listed applicant for Treace Medical Systems (TMC) Plating System?

FDA 510(k)记录中列出Treace Medical Concepts, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Treace Medical Systems (TMC) Plating System?

The FDA product code for Treace Medical Systems (TMC) Plating System is HRS.

列明Treace Medical Concepts, 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。

K262963TMC植入固定系统 K260361Treace医疗概念（TMC）螺钉固定系统 K242671Treace医疗概念（TMC）螺钉固定系统 K221181Treace医疗概念（TMC）板系统 K222564Treace医疗概念（TMC）锤状趾固定系统 K220136Treace医疗概念（TMC）板系统

查看所有 15 个设备 →

相关器械（代码：HRS）

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。

K261892ProRib 固定系统Costa Surgical, Inc.K262098增强型聚醚醚酮（PEEK）拇外翻矫正系统Nvision Biomedical Technologies K262963TMC植入固定系统Treace Medical Concepts, Inc.K261647Tempo电镀系统；超压缩螺钉系统Pace Surgical K261830FRAXION 3.5 板系统（多种 - 见目录）；FRAXION 4.5 板系统（多种 - 见目录）；FRAXION 迷你板系统（多种 - 见目录）；FRAXION 骨螺钉系统（多种 - 见目录）Ortler Global Tibbi Gerecler Anonim Sirketi K262537Versalock无菌敷贴系统GM Dos Reis Industria e Comercio Ltda.

官方来源

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