FDA 510(k)

Curiteva 中线前颈椎板系统（或Curiteva 前颈椎板系统）

K号: K181549 · 2018-08-03

决定日期2018-08-03

产品代码KWQ

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

Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) is the device name listed in this FDA 510(k) record. The listed applicant is Curiteva, LLC. It received FDA 510(k) clearance on 2018-08-03 under 510(k) number K181549. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)?

Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) is a medical device that received FDA 510(k) clearance on 2018-08-03. The listed applicant is Curiteva, LLC. The 510(k) number is K181549.

When did Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) receive FDA 510(k) clearance?

Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) received FDA 510(k) clearance on 2018-08-03, under 510(k) number K181549.

Who is the listed applicant for Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)?

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

What is the FDA product code for Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)?

The FDA product code for Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) is KWQ.

列明Curiteva, 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。

K181589Curiteva 腰椎椎间融合系统 K181562Curiteva 前颈椎板系统 K181261Curiteva 颈椎椎间融合系统

官方来源

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