FDA 510(k)

上海三友CARMEN颈椎融合系统

K号: K163366 · 2017-10-05

决定日期2017-10-05

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

Shanghai Sanyou CARMEN Cervical Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2017-10-05 under 510(k) number K163366. 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 Shanghai Sanyou CARMEN Cervical Fusion System?

Shanghai Sanyou CARMEN Cervical Fusion System is a medical device that received FDA 510(k) clearance on 2017-10-05. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K163366.

When did Shanghai Sanyou CARMEN Cervical Fusion System receive FDA 510(k) clearance?

Shanghai Sanyou CARMEN Cervical Fusion System received FDA 510(k) clearance on 2017-10-05, under 510(k) number K163366.

Who is the listed applicant for Shanghai Sanyou CARMEN Cervical Fusion System?

The FDA 510(k) record lists Shanghai Sanyou Medical Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shanghai Sanyou CARMEN Cervical Fusion System?

The FDA product code for Shanghai Sanyou CARMEN Cervical Fusion System is KWQ.

列明Shanghai Sanyou Medical Co, Ltd.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。

K230872Halis® 腰椎椎体系统，Lydia® 前路腰椎融合系统，Dica® 方向可变腰椎椎体系统，KEYSTONE 椎体系统 K230961宙斯脊柱系统 K231931Adena-Zina脊柱系统 K211689KEYSTONE PEEK笼系统 K212066Adena-Zina系统 K163422上海三友PEEK笼系统

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官方来源

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