FDA 510(k)

DeGen 医疗患者特异性植入物（PSI）系统

K号: K241077 · 2024-10-29

决定日期2024-10-29

产品代码OVD

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

DeGen Medical Patient Specific Implant (PSI) System is the device name listed in this FDA 510(k) record. The listed applicant is Degen Medical. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K241077. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DeGen Medical Patient Specific Implant (PSI) System?

DeGen Medical Patient Specific Implant (PSI) System is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Degen Medical. The 510(k) number is K241077.

When did DeGen Medical Patient Specific Implant (PSI) System receive FDA 510(k) clearance?

DeGen Medical Patient Specific Implant (PSI) System received FDA 510(k) clearance on 2024-10-29, under 510(k) number K241077.

Who is the listed applicant for DeGen Medical Patient Specific Implant (PSI) System?

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

What is the FDA product code for DeGen Medical Patient Specific Implant (PSI) System?

The FDA product code for DeGen Medical Patient Specific Implant (PSI) System is OVD.

列明Degen 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。

K251829DeGen 医疗患者特异性植入物（PSI）系统 K252737DeGen 医疗 Latitude-C AM 颈椎椎间盘融合系统 K250667DeGen 医疗患者特异性植入物（PSI）系统 K231199Solar Lumbar Interbody Fusion System K223418DeGen Impulse AM™ 系统 K213918DeGen 导航工具

查看所有 13 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。