FDA 510(k)

Pinnacle Duofix HA 髋臼杯假体

K号: K192919 · 2019-11-26

决定日期2019-11-26

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

Pinnacle Duofix HA Acetabular Cup Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192919. 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 Pinnacle Duofix HA Acetabular Cup Prosthesis?

Pinnacle Duofix HA Acetabular Cup Prosthesis is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K192919.

When did Pinnacle Duofix HA Acetabular Cup Prosthesis receive FDA 510(k) clearance?

Pinnacle Duofix HA Acetabular Cup Prosthesis received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192919.

Who is the listed applicant for Pinnacle Duofix HA Acetabular Cup Prosthesis?

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

What is the FDA product code for Pinnacle Duofix HA Acetabular Cup Prosthesis?

The FDA product code for Pinnacle Duofix HA Acetabular Cup Prosthesis is LPH.

列明DePuy Orthopaedics, 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。

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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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