FDA 510(k)

AUDERE腰椎间隙系统

K号: K193457 · 2020-05-12

决定日期2020-05-12

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

AUDERE Lumbar Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Met One Technologies. It received FDA 510(k) clearance on 2020-05-12 under 510(k) number K193457. 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 AUDERE Lumbar Spacer System?

AUDERE Lumbar Spacer System is a medical device that received FDA 510(k) clearance on 2020-05-12. The listed applicant is Met One Technologies. The 510(k) number is K193457.

When did AUDERE Lumbar Spacer System receive FDA 510(k) clearance?

AUDERE Lumbar Spacer System received FDA 510(k) clearance on 2020-05-12, under 510(k) number K193457.

Who is the listed applicant for AUDERE Lumbar Spacer System?

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

What is the FDA product code for AUDERE Lumbar Spacer System?

The FDA product code for AUDERE Lumbar Spacer System is MAX.

列明Met One Technologies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。

K180772Met One Czar前颈椎板系统 K170108Xultan 5.5 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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