FDA 510(k)

颈椎脊柱支架系统接骨板解决方案（CSTS-PS）

K号: K212527 · 2022-05-17

决定日期2022-05-17

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

Cervical Spine Truss System Plating Solution (CSTS-PS) is the device name listed in this FDA 510(k) record. The listed applicant is 4Web Medical, Inc.. It received FDA 510(k) clearance on 2022-05-17 under 510(k) number K212527. 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 Cervical Spine Truss System Plating Solution (CSTS-PS)?

Cervical Spine Truss System Plating Solution (CSTS-PS) is a medical device that received FDA 510(k) clearance on 2022-05-17. The listed applicant is 4Web Medical, Inc.. The 510(k) number is K212527.

When did Cervical Spine Truss System Plating Solution (CSTS-PS) receive FDA 510(k) clearance?

Cervical Spine Truss System Plating Solution (CSTS-PS) received FDA 510(k) clearance on 2022-05-17, under 510(k) number K212527.

Who is the listed applicant for Cervical Spine Truss System Plating Solution (CSTS-PS)?

The FDA 510(k) record lists 4Web Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cervical Spine Truss System Plating Solution (CSTS-PS)?

The FDA product code for Cervical Spine Truss System Plating Solution (CSTS-PS) is KWQ.

列明4Web Medical, Inc.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。

K253200颈椎脊柱支架系统-独立（CSTS-SA）K240388骨切开撑架系统（OTS）K233966前脊柱支架系统-Stand Alone (ASTS-SA)K230088Ankle Truss System (ATS)K231739颈椎脊柱支架系统（CSTS）K223362颈椎脊柱支架系统-独立（CSTS-SA）椎间融合装置

查看所有 11 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。