FDA 510(k)

Treace医疗概念（TMC）螺钉固定系统

K号: K260361 · 2026-03-06

决定日期2026-03-06

产品代码HWC

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 Concepts (TMC) Screw Fixation 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 2026-03-06 under 510(k) number K260361. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Treace Medical Concepts (TMC) Screw Fixation System?

Treace Medical Concepts (TMC) Screw Fixation System is a medical device that received FDA 510(k) clearance on 2026-03-06. The listed applicant is Treace Medical Concepts, Inc.. The 510(k) number is K260361.

When did Treace Medical Concepts (TMC) Screw Fixation System receive FDA 510(k) clearance?

Treace Medical Concepts (TMC) Screw Fixation System received FDA 510(k) clearance on 2026-03-06, under 510(k) number K260361.

Who is the listed applicant for Treace Medical Concepts (TMC) Screw Fixation 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 Concepts (TMC) Screw Fixation System?

The FDA product code for Treace Medical Concepts (TMC) Screw Fixation System is HWC. This falls under the Cardiovascular category.

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。

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