FDA 510(k)

Klassic膝关节翻修系统

K号: K230537 · 2023-05-19

决定日期2023-05-19

产品代码JWH

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

Klassic Knee Revision System is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2023-05-19 under 510(k) number K230537. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Klassic Knee Revision System?

Klassic Knee Revision System is a medical device that received FDA 510(k) clearance on 2023-05-19. The listed applicant is Total Joint Othopedics, Inc.. The 510(k) number is K230537.

When did Klassic Knee Revision System receive FDA 510(k) clearance?

Klassic Knee Revision System received FDA 510(k) clearance on 2023-05-19, under 510(k) number K230537.

Who is the listed applicant for Klassic Knee Revision System?

The FDA 510(k) record lists Total Joint Othopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Klassic Knee Revision System?

The FDA product code for Klassic Knee Revision System is JWH.

列明Total Joint Othopedics, 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。

K243991Klassic膝关节系统 - 修订胫骨基板 K232414Klassic®胫骨插入物，PS-Post，Klassic全聚乙烯胫骨，PS-Post K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length K191399BIOLOX CONTOURA 骨股头 K171962Klassic HD®髋关节系统 K161073Klassic HD髋关节系统

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官方来源

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