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FDA 510(k)

Klassic膝关节系统 - Klassic膝关节PS-Post股骨;Klassic膝关节胫骨插入物,PS-Post,标准聚乙烯;Klassic膝关节胫骨插入物,PS-Post,E-Link聚乙烯

K号: K183596 · 2019-03-29

决定日期2019-03-29
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 System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-03-29 under 510(k) number K183596. 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 System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly?

Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly is a medical device that received FDA 510(k) clearance on 2019-03-29. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K183596.

When did Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly receive FDA 510(k) clearance?

Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly received FDA 510(k) clearance on 2019-03-29, under 510(k) number K183596.

Who is the listed applicant for Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly?

FDA 510(k)记录将Total Joint Orthopedics, Inc.列为申请人。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 Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly?

The FDA product code for Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly is JWH.

相关临床试验

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。

列明Total Joint Orthopedics, 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。

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相关器械(代码:JWH)

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。

官方来源

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