FDA 510(k)

髌股关节波浪（Kahuna）关节成形术系统

K号: K181280 · 2018-06-14

决定日期2018-06-14

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

Patello-Femoral Wave (Kahuna) Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K181280. 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 Patello-Femoral Wave (Kahuna) Arthroplasty System?

Patello-Femoral Wave (Kahuna) Arthroplasty System is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K181280.

When did Patello-Femoral Wave (Kahuna) Arthroplasty System receive FDA 510(k) clearance?

Patello-Femoral Wave (Kahuna) Arthroplasty System received FDA 510(k) clearance on 2018-06-14, under 510(k) number K181280.

Who is the listed applicant for Patello-Femoral Wave (Kahuna) Arthroplasty System?

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

What is the FDA product code for Patello-Femoral Wave (Kahuna) Arthroplasty System?

The FDA product code for Patello-Femoral Wave (Kahuna) Arthroplasty System is KRR.

列明Arthrosurface, 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。

K203375OVOMotion 反向肩关节置换系统 K200718Arthrosurface WristMotion 全腕关节置换系统 K190261BOSS 脚趾固定系统 K173964OVOMotion 肩关节置换系统 K172383Arthrosurface 骨螺钉 K170440KISSloc 缝合系统

查看所有 11 个设备 →

官方来源

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