FDA 510(k)

Longboard 修订髋关节假体

K号: K243021 · 2025-08-07

决定日期2025-08-07

产品代码LZO

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

Longboard Revision Hip Stem 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 2025-08-07 under 510(k) number K243021. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Longboard Revision Hip Stem?

Longboard Revision Hip Stem is a medical device that received FDA 510(k) clearance on 2025-08-07. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K243021.

When did Longboard Revision Hip Stem receive FDA 510(k) clearance?

Longboard Revision Hip Stem received FDA 510(k) clearance on 2025-08-07, under 510(k) number K243021.

Who is the listed applicant for Longboard Revision Hip Stem?

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 Longboard Revision Hip Stem?

The FDA product code for Longboard Revision Hip Stem is LZO.

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。

K252824Evolve AP 杯，世界鳍杯，世界 G-Zero 内衬和奇球股骨头 K253239Active-V 全膝关节系统；世界全膝关节系统 K251771Cambridge 部分膝关节 K242674Freedom颈椎后路螺钉 K242477肩部软组织锚定器 K243043Origin™ 带水泥的髋关节柄

查看所有 42 个设备 →

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。