FDA 510(k)

BiMobile 工具（用于 BiMobile 双关节系统）

K号: K211567 · 2022-06-03

决定日期2022-06-03

产品代码LZO

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

BiMobile Instruments (for BiMobile Dual Mobility System) is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2022-06-03 under 510(k) number K211567. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BiMobile Instruments (for BiMobile Dual Mobility System)?

BiMobile Instruments (for BiMobile Dual Mobility System) is a medical device that received FDA 510(k) clearance on 2022-06-03. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K211567.

When did BiMobile Instruments (for BiMobile Dual Mobility System) receive FDA 510(k) clearance?

BiMobile Instruments (for BiMobile Dual Mobility System) received FDA 510(k) clearance on 2022-06-03, under 510(k) number K211567.

Who is the listed applicant for BiMobile Instruments (for BiMobile Dual Mobility System)?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BiMobile Instruments (for BiMobile Dual Mobility System)?

The FDA product code for BiMobile Instruments (for BiMobile Dual Mobility System) is LZO.

列明Waldemar Link GmbH & Co. KG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。

K261009MobileLink 髋臼杯系统 – 40mm ID 插件（多种）K250375Allure髋关节柄和髓内塞子 K243927MobileLink 髋臼杯系统 - 内部涂层 K241636MobileLink 髋臼杯系统 - 扩展线（多个）K231445LINK Embrace 肩关节系统 - 反向配置 K222066LINK MobileLink 髋臼杯系统

查看所有 30 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。