FDA 510(k)

提贡医疗静态标枪全缝合锚及标枪全缝合锚线

K号: K260921 · 2026-04-21

决定日期2026-04-21

产品代码MBI

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

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line is the device name listed in this FDA 510(k) record. The listed applicant is Tigon Medical. It received FDA 510(k) clearance on 2026-04-21 under 510(k) number K260921. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line?

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line is a medical device that received FDA 510(k) clearance on 2026-04-21. The listed applicant is Tigon Medical. The 510(k) number is K260921.

When did Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line receive FDA 510(k) clearance?

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line received FDA 510(k) clearance on 2026-04-21, under 510(k) number K260921.

Who is the listed applicant for Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line?

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

What is the FDA product code for Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line?

The FDA product code for Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line is MBI.

列明Tigon Medical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。

K252596提贡医疗无结和双箭头全缝合锚 K242529提贡医疗全缝合锚（ASA）K240175提贡医疗骨折、不稳和重建（FIRE）K220464提贡医疗鹰隼锚线 K211049提贡医疗按钮系统 K182507提贡医疗组织锚

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官方来源

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