FDA 510(k)

Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF

K号: K212389 · 2021-10-29

决定日期2021-10-29

产品代码MAX

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

Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF is the device name listed in this FDA 510(k) record. The listed applicant is Intelivation, LLC. It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K212389. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF?

Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Intelivation, LLC. The 510(k) number is K212389.

When did Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF receive FDA 510(k) clearance?

Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF received FDA 510(k) clearance on 2021-10-29, under 510(k) number K212389.

Who is the listed applicant for Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF?

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

What is the FDA product code for Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF?

The FDA product code for Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF is MAX.

列明Intelivation, 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。

K212185Golden Isles 椎弓根螺钉系统

相关器械（代码：MAX）

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。

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官方来源

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