FDA 510(k)

Evolve AP 杯，世界鳍杯，世界 G-Zero 内衬和奇球股骨头

K号: K252824 · 2026-03-12

决定日期2026-03-12

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

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K252824. 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 Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head?

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K252824.

When did Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head receive FDA 510(k) clearance?

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head received FDA 510(k) clearance on 2026-03-12, under 510(k) number K252824.

Who is the listed applicant for Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head?

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

What is the FDA product code for Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head?

The FDA product code for Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head is JDI.

列明Signature Orthopaedics Pty, 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。

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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.K243571trabecular金属髋臼翻修系统，髋臼衬垫和限制性衬垫Zimmer Biomet 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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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。