FDA 510(k)

SmartBase for Arthrex Glenoid IRIS

K号: K153215 · 2016-02-19

决定日期2016-02-19

产品代码KWS

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

SmartBase for Arthrex Glenoid IRIS is the device name listed in this FDA 510(k) record. The listed applicant is Custom Orthopaedic Solutions, Inc.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K153215. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SmartBase for Arthrex Glenoid IRIS?

SmartBase for Arthrex Glenoid IRIS is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Custom Orthopaedic Solutions, Inc.. The 510(k) number is K153215.

When did SmartBase for Arthrex Glenoid IRIS receive FDA 510(k) clearance?

SmartBase for Arthrex Glenoid IRIS received FDA 510(k) clearance on 2016-02-19, under 510(k) number K153215.

Who is the listed applicant for SmartBase for Arthrex Glenoid IRIS?

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

What is the FDA product code for SmartBase for Arthrex Glenoid IRIS?

The FDA product code for SmartBase for Arthrex Glenoid IRIS is KWS.

列明Custom Orthopaedic Solutions, 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。

K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal K153612ArthrexVIP 网络门户

官方来源

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