FDA 510(k)

APEX 3D 全踝关节置换系统

K号: K250641 · 2025-05-01

决定日期2025-05-01

产品代码HSN

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

APEX 3D Total Ankle Replacement System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2025-05-01 under 510(k) number K250641. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the APEX 3D Total Ankle Replacement System?

APEX 3D Total Ankle Replacement System is a medical device that received FDA 510(k) clearance on 2025-05-01. The listed applicant is Paragon 28, Inc.. The 510(k) number is K250641.

When did APEX 3D Total Ankle Replacement System receive FDA 510(k) clearance?

APEX 3D Total Ankle Replacement System received FDA 510(k) clearance on 2025-05-01, under 510(k) number K250641.

Who is the listed applicant for APEX 3D Total Ankle Replacement System?

FDA 510(k)记录中列出Paragon 28, Inc.为申请人。这本身并不能确立该设备制造商。

What is the FDA product code for APEX 3D Total Ankle Replacement System?

The FDA product code for APEX 3D Total Ankle Replacement System is HSN.

列明Paragon 28, Inc.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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