FDA 510(k)

Syntheface PEEK干扰螺钉，Syntheface PEEK螺钉套管

K号: K230874 · 2023-05-23

决定日期2023-05-23

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

Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath 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 2023-05-23 under 510(k) number K230874. 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 Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath?

Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath is a medical device that received FDA 510(k) clearance on 2023-05-23. The listed applicant is Suzhou Endophix Co., Ltd.. The 510(k) number is K230874.

When did Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath receive FDA 510(k) clearance?

Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath received FDA 510(k) clearance on 2023-05-23, under 510(k) number K230874.

Who is the listed applicant for Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath?

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 Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath?

The FDA product code for Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath 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 K232725Javelot Ti 缝合锚钉，Javelot Ti-D 缝合锚钉 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）

官方来源

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