FDA 510(k)

Bencox M Stem（Bencox 髋关节系统）和Bencox ID 固定茎（带中心器）& Bencox 骨塞

K号: K152084 · 2016-04-29

决定日期2016-04-29

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

Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug is the device name listed in this FDA 510(k) record. The listed applicant is Corentec Co., Ltd.. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K152084. 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 Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug?

Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K152084.

When did Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug receive FDA 510(k) clearance?

Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug received FDA 510(k) clearance on 2016-04-29, under 510(k) number K152084.

Who is the listed applicant for Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug?

The FDA 510(k) record lists Corentec Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug?

The FDA product code for Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug is LPH.

列明Corentec Co., Ltd.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。

K250889EXULT 膝关节置换系统 K242401EXULT 膝关节置换系统 K242046EXULT 膝关节置换系统 K223828BENCOX Delta Option Heads K223223BENCOX Mirabo Z Cup Cortinium K222278LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation

查看所有 21 个设备 →

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

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。