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FDA 510(k)

MPO髋关节乙二醇灭菌供应商变更

K号: K240046 · 2024-04-18

申请人Microport Orthopedics
决定日期2024-04-18
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

Ethylene Oxide Sterilization Supplier Change for MPO Hips is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics. It received FDA 510(k) clearance on 2024-04-18 under 510(k) number K240046. 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 Ethylene Oxide Sterilization Supplier Change for MPO Hips?

Ethylene Oxide Sterilization Supplier Change for MPO Hips is a medical device that received FDA 510(k) clearance on 2024-04-18. The listed applicant is Microport Orthopedics. The 510(k) number is K240046.

When did Ethylene Oxide Sterilization Supplier Change for MPO Hips receive FDA 510(k) clearance?

Ethylene Oxide Sterilization Supplier Change for MPO Hips received FDA 510(k) clearance on 2024-04-18, under 510(k) number K240046.

Who is the listed applicant for Ethylene Oxide Sterilization Supplier Change for MPO Hips?

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

What is the FDA product code for Ethylene Oxide Sterilization Supplier Change for MPO Hips?

The FDA product code for Ethylene Oxide Sterilization Supplier Change for MPO Hips is LPH.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 BiometK253630Mpact 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 OrthopaedicsK243192iNSitu 侧向髋臼衬垫，iNSitu 带等离子喷涂 CPTi 涂层的股骨柄Nextstep Arthopedix, LLCK251270Taperloc® 完整髋臼柄Biomet, Inc.

官方来源

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