FDA 510(k)

Amendia 腰椎融合装置

K号: K160924 · 2016-11-08

决定日期2016-11-08

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

Amendia Interbody Fusion Devices is the device name listed in this FDA 510(k) record. The listed applicant is Amendia, Inc.. It received FDA 510(k) clearance on 2016-11-08 under 510(k) number K160924. 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 Amendia Interbody Fusion Devices?

Amendia Interbody Fusion Devices is a medical device that received FDA 510(k) clearance on 2016-11-08. The listed applicant is Amendia, Inc.. The 510(k) number is K160924.

When did Amendia Interbody Fusion Devices receive FDA 510(k) clearance?

Amendia Interbody Fusion Devices received FDA 510(k) clearance on 2016-11-08, under 510(k) number K160924.

Who is the listed applicant for Amendia Interbody Fusion Devices?

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

What is the FDA product code for Amendia Interbody Fusion Devices?

The FDA product code for Amendia Interbody Fusion Devices is MAX.

列明Amendia, 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。

K161842Overwatch脊柱系统 K152920Savannah-T® 椎弓根螺钉系统 K153152Syzygy稳定系统 K160291Optimus ALIF 系统 K152972Amendia 独立颈椎系统 K151310Amendia 腰椎融合装置

查看所有 7 个设备 →

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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