FDA 510(k)

Renovis Tesera C/Tesera SC 前颈椎融合 (ACF) 系统

K号: K182007 · 2018-12-07

决定日期2018-12-07

产品代码OVD

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

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is the device name listed in this FDA 510(k) record. The listed applicant is Renovis Surgical Technologies. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K182007. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System?

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Renovis Surgical Technologies. The 510(k) number is K182007.

When did Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System receive FDA 510(k) clearance?

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System received FDA 510(k) clearance on 2018-12-07, under 510(k) number K182007.

Who is the listed applicant for Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System?

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

What is the FDA product code for Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System?

The FDA product code for Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is OVD.

列明Renovis Surgical 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。

K190122Renovis A200 PS 膝关节系统作为 Renovis A200 膝关节系统的一部分 K181655Renovis S180 侧方腰椎椎间融合系统 K171543Renovis 手术髋关节置换系统 K170888Renovis S141 腰椎椎间融合系统 K153250Renovis Tesera SC 独立式前颈椎融合（ACF）系统

官方来源

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