FDA 510(k)

Cadence Ankle PSI System

K号: K241326 · 2024-08-30

决定日期2024-08-30

产品代码OYK

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

Cadence Ankle PSI System is the device name listed in this FDA 510(k) record. The listed applicant is 3D Systems, Inc.. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K241326. The device is classified under product code OYK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cadence Ankle PSI System?

Cadence Ankle PSI System is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is 3D Systems, Inc.. The 510(k) number is K241326.

When did Cadence Ankle PSI System receive FDA 510(k) clearance?

Cadence Ankle PSI System received FDA 510(k) clearance on 2024-08-30, under 510(k) number K241326.

Who is the listed applicant for Cadence Ankle PSI System?

The FDA 510(k) record lists 3D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cadence Ankle PSI System?

The FDA product code for Cadence Ankle PSI System is OYK.

列明3D Systems, 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。

K261826VSP系统（钛聘弓）K250711VSP骨科系统 K243174Cadence Ankle PSI System K243173Salto Talaris踝关节PSI系统 K241148Salto Talaris踝关节PSI系统 K231834VSP PEEK 颅骨植入物

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