FDA 510(k)

Klassic膝关节系统 - 标准聚乙烯的Sombrero髌骨，Klassic膝关节系统 - E-Link聚乙烯的Sombrero髌骨

K号: K190280 · 2019-03-15

决定日期2019-03-15

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 - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with 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 2019-03-15 under 510(k) number K190280. 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 - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly?

Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K190280.

When did Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly receive FDA 510(k) clearance?

Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly received FDA 510(k) clearance on 2019-03-15, under 510(k) number K190280.

Who is the listed applicant for Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with 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 - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly?

The FDA product code for Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly is JWH.

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。

K261734经典感染间隔系统 K220483Platform® 骨盆系统 K211877Klassic膝关节系统 K211602Klassic膝关节系统 K202740Klassic膝关节系统胫骨插入物，PS-Max K183596Klassic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

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官方来源

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