FDA 510(k)

GENFlex2 全膝关节系统 - 超高一致性 CR 股骨远端插入物

K号: K173875 · 2018-01-19

决定日期2018-01-19

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

GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast, Inc.. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K173875. 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 GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert?

GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Stelkast, Inc.. The 510(k) number is K173875.

When did GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert receive FDA 510(k) clearance?

GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert received FDA 510(k) clearance on 2018-01-19, under 510(k) number K173875.

Who is the listed applicant for GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert?

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

What is the FDA product code for GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert?

The FDA product code for GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert is JWH.

列明Stelkast, 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。

K190276Provident II 髋臼杯 K162222GENflex2 全膝关节系统

官方来源

在 FDA 数据库中查看 →

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。