FDA 510(k)

FlexWing 前颈椎板系统

K号: K231251 · 2024-07-24

决定日期2024-07-24

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

FlexWing Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K231251. 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 FlexWing Anterior Cervical Plate System?

FlexWing Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Jeil Medical Corporation. The 510(k) number is K231251.

When did FlexWing Anterior Cervical Plate System receive FDA 510(k) clearance?

FlexWing Anterior Cervical Plate System received FDA 510(k) clearance on 2024-07-24, under 510(k) number K231251.

Who is the listed applicant for FlexWing Anterior Cervical Plate System?

The FDA 510(k) record lists Jeil Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FlexWing Anterior Cervical Plate System?

The FDA product code for FlexWing Anterior Cervical Plate System is KWQ.

列明Jeil Medical Corporation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。

K252246Leforte MMF 系统 K252826ARIX 股骨钉系统 K251431FIX-C PEEK ACIF SA 系统 K243973FIX-L PEEK PLIF 和 T-PLIF 系统 K242751ARIX 胸骨条系统 K242247ARIX 股骨钉系统

查看所有 35 个设备 →

官方来源

在 FDA 数据库中查看 →

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。