FDA 510(k)

X-PAC® N-GAGE™ 腰椎板系统

K号: K250602 · 2025-05-20

决定日期2025-05-20

产品代码KWQ

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

X-PAC® N-GAGE™ Lumbar Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Expanding Innovations, Inc.. It received FDA 510(k) clearance on 2025-05-20 under 510(k) number K250602. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the X-PAC® N-GAGE™ Lumbar Plate System?

X-PAC® N-GAGE™ Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2025-05-20. The listed applicant is Expanding Innovations, Inc.. The 510(k) number is K250602.

When did X-PAC® N-GAGE™ Lumbar Plate System receive FDA 510(k) clearance?

X-PAC® N-GAGE™ Lumbar Plate System received FDA 510(k) clearance on 2025-05-20, under 510(k) number K250602.

Who is the listed applicant for X-PAC® N-GAGE™ Lumbar Plate System?

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

What is the FDA product code for X-PAC® N-GAGE™ Lumbar Plate System?

The FDA product code for X-PAC® N-GAGE™ Lumbar Plate System is KWQ.

列明Expanding Innovations, Inc.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。

K251003X-PAC® LLIF可扩展侧向笼系统 K251617X-PAC® TLIF可扩张后路笼系统；X-PAC® LLIF可扩张侧路笼系统 K223174X-Pac可扩展LLIF笼系统 K222797X-Pac可扩展腰椎笼系统 K220655X-Pac可扩展腰椎笼系统 K203802X-Pac可扩展腰椎笼系统

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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。