FDA 510(k)

Javelot Ti 缝合锚钉，Javelot Ti-D 缝合锚钉

K号: K232725 · 2023-11-02

决定日期2023-11-02

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

Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Endophix Co., Ltd.. It received FDA 510(k) clearance on 2023-11-02 under 510(k) number K232725. 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 Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor?

Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-11-02. The listed applicant is Suzhou Endophix Co., Ltd.. The 510(k) number is K232725.

When did Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor receive FDA 510(k) clearance?

Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor received FDA 510(k) clearance on 2023-11-02, under 510(k) number K232725.

Who is the listed applicant for Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor?

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

What is the FDA product code for Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor?

The FDA product code for Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor is MBI.

列明Suzhou Endophix 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。

K232941Megaloop按钮系统 K231002Javelot PK-S 缝合锚钉，Javelot PK-S 缝合锚钉（无结），Javelot PK-P 缝合锚钉，Javelot PK-P 缝合锚钉（无结），Javelot PK-L 缝合锚钉（无结）K230874Syntheface PEEK干扰螺钉，Syntheface PEEK螺钉套管

官方来源

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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。