FDA 510(k)

Overture Orthopaedics髌股系统

K号: K231253 · 2023-07-07

决定日期2023-07-07

产品代码KRR

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

Overture Orthopaedics Patellofemoral System is the device name listed in this FDA 510(k) record. The listed applicant is Overture Resurfacing, Inc.. It received FDA 510(k) clearance on 2023-07-07 under 510(k) number K231253. The device is classified under product code KRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Overture Orthopaedics Patellofemoral System?

Overture Orthopaedics Patellofemoral System is a medical device that received FDA 510(k) clearance on 2023-07-07. The listed applicant is Overture Resurfacing, Inc.. The 510(k) number is K231253.

When did Overture Orthopaedics Patellofemoral System receive FDA 510(k) clearance?

Overture Orthopaedics Patellofemoral System received FDA 510(k) clearance on 2023-07-07, under 510(k) number K231253.

Who is the listed applicant for Overture Orthopaedics Patellofemoral System?

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

What is the FDA product code for Overture Orthopaedics Patellofemoral System?

The FDA product code for Overture Orthopaedics Patellofemoral System is KRR.

列明Overture Resurfacing, Inc.为申报人的其他记录

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