FDA 510(k)

4CIS SARA脊柱系统，4CIS VERTU脊柱系统

K号: K202498 · 2021-02-18

申请人Solco Biomedical Company India Private Limited

决定日期2021-02-18

产品代码NKB

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

4CIS SARA Spine System, 4CIS VERTU Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Solco Biomedical Company India Private Limited. It received FDA 510(k) clearance on 2021-02-18 under 510(k) number K202498. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 4CIS SARA Spine System, 4CIS VERTU Spine System?

4CIS SARA Spine System, 4CIS VERTU Spine System is a medical device that received FDA 510(k) clearance on 2021-02-18. The listed applicant is Solco Biomedical Company India Private Limited. The 510(k) number is K202498.

When did 4CIS SARA Spine System, 4CIS VERTU Spine System receive FDA 510(k) clearance?

4CIS SARA Spine System, 4CIS VERTU Spine System received FDA 510(k) clearance on 2021-02-18, under 510(k) number K202498.

Who is the listed applicant for 4CIS SARA Spine System, 4CIS VERTU Spine System?

The FDA 510(k) record lists Solco Biomedical Company India Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4CIS SARA Spine System, 4CIS VERTU Spine System?

The FDA product code for 4CIS SARA Spine System, 4CIS VERTU Spine System is NKB.

列明Solco Biomedical Company India Private Limited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。

K2136534CIS BLACK MARLIN PLIF CAGE系统，4CIS DOLPHIN TLIF CAGE系统

相关器械（代码：NKB）

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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