FDA 510(k)

F3D 脊柱切除术系统

K号: K202637 · 2020-12-23

决定日期2020-12-23

产品代码MQP

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

F3D Corpectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Corelink, LLC. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K202637. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the F3D Corpectomy System?

F3D Corpectomy System is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Corelink, LLC. The 510(k) number is K202637.

When did F3D Corpectomy System receive FDA 510(k) clearance?

F3D Corpectomy System received FDA 510(k) clearance on 2020-12-23, under 510(k) number K202637.

Who is the listed applicant for F3D Corpectomy System?

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

What is the FDA product code for F3D Corpectomy System?

The FDA product code for F3D Corpectomy System is MQP.

列明Corelink, LLC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。

K231743F3D 侧方腰椎椎间系统，CL5 侧方腰椎椎间系统，以及奥罗侧方板系统 K231494CoreLink 机器人导航仪器 K232116CoreLink 导航仪器 K230329F3D 椎间系统 K230880CoreLink 导航仪器 K223708Entasis 3D 双电极骶髂关节植入系统

查看所有 23 个设备 →

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。