FDA 510(k)

trabecular金属髋臼翻修系统，髋臼衬垫和限制性衬垫

K号: K243571 · 2025-07-31

决定日期2025-07-31

产品代码JDI

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

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Biomet. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K243571. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners?

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is Zimmer Biomet. The 510(k) number is K243571.

When did Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners receive FDA 510(k) clearance?

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners received FDA 510(k) clearance on 2025-07-31, under 510(k) number K243571.

Who is the listed applicant for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners?

FDA 510(k)记录显示Zimmer Biomet为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners?

The FDA product code for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners is JDI.

列明Zimmer Biomet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。

K261453G7® 髋臼系统 K251834Persona部分膝关节 K251620A.L.P.S. 肱骨近端钢板系统 K250834Zimmer Biomet 陶瓷头（直径22.2毫米）K243293Zimmer® Persona® 定制膝关节系统

相关器械（代码：JDI）

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。

K253515Zimmer Biomet OSS™ 骨科抢救系统 OsseoTi® 套管和增强件Biomet Orthopedics, Inc.K253434OSSTM骨科抢救系统Biomet, Inc.K252824Evolve AP 杯，世界鳍杯，世界 G-Zero 内衬和奇球股骨头Signature Orthopaedics Pty, Ltd.K240783Anthology髋臼柄；CPCS髋臼柄；股骨头；R3髋臼衬垫；Spectron髋臼柄；Synergy髋臼柄Smith & Nephew, Inc.K241716全球模块化替换系统，模块化替换系统，模块化旋转铰链膝关节组件Howmedica Osteonics Corp., Dba Stryker Orthopaedics K240418Stryker骨科髋部系统标签更新Howmedica Osteonics Corp., Dba Stryker Orthopaedics

官方来源

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