FDA 510(k)

钛涂层肱骨头

K号: K191698 · 2020-07-16

决定日期2020-07-16

产品代码KWT

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

TiN Coated Humeral Head is the device name listed in this FDA 510(k) record. The listed applicant is Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2020-07-16 under 510(k) number K191698. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TiN Coated Humeral Head?

TiN Coated Humeral Head is a medical device that received FDA 510(k) clearance on 2020-07-16. The listed applicant is Fx Shoulder USA, Inc.. The 510(k) number is K191698.

When did TiN Coated Humeral Head receive FDA 510(k) clearance?

TiN Coated Humeral Head received FDA 510(k) clearance on 2020-07-16, under 510(k) number K191698.

Who is the listed applicant for TiN Coated Humeral Head?

The FDA 510(k) record lists Fx Shoulder USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TiN Coated Humeral Head?

The FDA product code for TiN Coated Humeral Head is KWT.

列明Fx Shoulder USA, 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。

K240278全楔形侧向和增强基板 K223801FX V135™ 肩关节假体 K222936Humeris® 135 肩系统 K213117FX V135 肩关节假体 K210790侧置和增强型基板 K201391Easytech® 解剖肩关节系统

查看所有 11 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。