FDA 510(k)

SpineEX Sagittae 横突腰椎椎间融合装置

K号: K181531 · 2018-10-05

决定日期2018-10-05

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

SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices is the device name listed in this FDA 510(k) record. The listed applicant is Spineex, Inc.. It received FDA 510(k) clearance on 2018-10-05 under 510(k) number K181531. 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 SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices?

SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices is a medical device that received FDA 510(k) clearance on 2018-10-05. The listed applicant is Spineex, Inc.. The 510(k) number is K181531.

When did SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices receive FDA 510(k) clearance?

SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices received FDA 510(k) clearance on 2018-10-05, under 510(k) number K181531.

Who is the listed applicant for SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices?

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

What is the FDA product code for SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices?

The FDA product code for SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices is MAX.

列明Spineex, 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。

K200816SpineEX Sagittae 横突腰椎椎间融合装置 K190193SpineEX Sagittae® 横突腰椎椎间融合装置

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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