FDA 510(k)

GMK 3D金属胫骨托延长件

K号: K253328 · 2026-02-26

决定日期2026-02-26

产品代码MBH

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

GMK 3D Metal Tibial Tray Extension is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K253328. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GMK 3D Metal Tibial Tray Extension?

GMK 3D Metal Tibial Tray Extension is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Medacta International S.A.. The 510(k) number is K253328.

When did GMK 3D Metal Tibial Tray Extension receive FDA 510(k) clearance?

GMK 3D Metal Tibial Tray Extension received FDA 510(k) clearance on 2026-02-26, under 510(k) number K253328.

Who is the listed applicant for GMK 3D Metal Tibial Tray Extension?

FDA 510(k)记录将Medacta International S.A.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for GMK 3D Metal Tibial Tray Extension?

The FDA product code for GMK 3D Metal Tibial Tray Extension is MBH.

列明Medacta International S.A.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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官方来源

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