FDA 510(k)

Remedy 股骨组件 84mm，Remedy 带柄膝关节间隙器

K号: K183017 · 2019-07-25

决定日期2019-07-25

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

Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer is the device name listed in this FDA 510(k) record. The listed applicant is Osteoremedies, LLC. It received FDA 510(k) clearance on 2019-07-25 under 510(k) number K183017. 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 Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer?

Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer is a medical device that received FDA 510(k) clearance on 2019-07-25. The listed applicant is Osteoremedies, LLC. The 510(k) number is K183017.

When did Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer receive FDA 510(k) clearance?

Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer received FDA 510(k) clearance on 2019-07-25, under 510(k) number K183017.

Who is the listed applicant for Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer?

FDA 510(k)记录中列出Osteoremedies, LLC为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer?

The FDA product code for Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer is JWH.

列明Osteoremedies, LLC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。

K262290REMEDY POLY+PLUS 快速适配髋臼杯 K253675OsteoRemedies 髋关节间隙系统 K250760SPECTRUM GV骨水泥 K242377REMEDY 带茎膝关节间隙垫系统，配备全聚乙烯胫骨组件 K231556SPECTRUM® GV骨水泥 K223650REMEDY 带茎膝关节间隙垫

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官方来源

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