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FDA 510(k)

SAGICO IBF 系统 - ARIA 腰椎，SAGICO IBF 系统 - ARION 颈椎

K号: K161710 · 2017-06-29

申请人Spinal Analytics & Geometrical Impant Co, LLC
决定日期2017-06-29
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

SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Analytics & Geometrical Impant Co, LLC. It received FDA 510(k) clearance on 2017-06-29 under 510(k) number K161710. 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 SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL?

SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL is a medical device that received FDA 510(k) clearance on 2017-06-29. The listed applicant is Spinal Analytics & Geometrical Impant Co, LLC. The 510(k) number is K161710.

When did SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL receive FDA 510(k) clearance?

SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL received FDA 510(k) clearance on 2017-06-29, under 510(k) number K161710.

Who is the listed applicant for SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL?

The FDA 510(k) record lists Spinal Analytics & Geometrical Impant Co, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL?

The FDA product code for SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL is MAX.

相关临床试验

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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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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