FDA 510(k)

LINK MobileLink® 髋臼杯系统 - 双活动度衬垫，壳/插入适配器

K号: K200607 · 2021-05-28

决定日期2021-05-28

产品代码LPH

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

LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters 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 2021-05-28 under 510(k) number K200607. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters?

LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters is a medical device that received FDA 510(k) clearance on 2021-05-28. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K200607.

When did LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters receive FDA 510(k) clearance?

LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters received FDA 510(k) clearance on 2021-05-28, under 510(k) number K200607.

Who is the listed applicant for LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters?

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 LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters?

The FDA product code for LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters is LPH.

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。

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相关器械（代码：LPH）

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。

K261453G7® 髋臼系统Zimmer Biomet K253630Mpact 3D金属泡沫Medacta International S.A.K254043TRIVANCE™ 髋关节假体Globus Medical, Inc.K261624Omnifit® 20°系列I插入件；Omnifit® Crossfire® 10°系列II插入件；限制性髋臼插入件；Trident® Crossfire® 0°聚乙烯插入件；Trident® Crossfire® 10°聚乙烯插入件；System 12 Crossfire® 10°插入件；Trident® 0°限制性髋臼插入件；Trident® 限制性髋臼衬垫；Trident® 全聚乙烯限制性髋臼插入件；Crossfire® 异心插入件10°；Artisan® 骨塞；UHR® 通用头双极组件Howmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu 侧向髋臼衬垫，iNSitu 带等离子喷涂 CPTi 涂层的股骨柄Nextstep Arthopedix, LLC K251270Taperloc® 完整髋臼柄Biomet, Inc.

官方来源

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