FDA 510(k)

AOS 前外侧近端肱骨钢板

K号: K160409 · 2016-03-15

决定日期2016-03-15

产品代码KTW

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

AOS Anterolateral Proximal Humeral Plate is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Orthopaedic Solutions, Inc.. It received FDA 510(k) clearance on 2016-03-15 under 510(k) number K160409. The device is classified under product code KTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AOS Anterolateral Proximal Humeral Plate?

AOS Anterolateral Proximal Humeral Plate is a medical device that received FDA 510(k) clearance on 2016-03-15. The listed applicant is Advanced Orthopaedic Solutions, Inc.. The 510(k) number is K160409.

When did AOS Anterolateral Proximal Humeral Plate receive FDA 510(k) clearance?

AOS Anterolateral Proximal Humeral Plate received FDA 510(k) clearance on 2016-03-15, under 510(k) number K160409.

Who is the listed applicant for AOS Anterolateral Proximal Humeral Plate?

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

What is the FDA product code for AOS Anterolateral Proximal Humeral Plate?

The FDA product code for AOS Anterolateral Proximal Humeral Plate is KTW.

列明Advanced 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。

K202489AOS 斐波那契下肢钢板系统 - AOS 近端胫骨钢板系统 K202099AOS 加利略™ 髋臼钉系统 K191598AOS ES 逆行股骨钉

官方来源

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