FDA 510(k)

Exeter V40股骨柄髋关节系统，Orthinox V40股骨头

K号: K173499 · 2018-03-19

决定日期2018-03-19

产品代码JDG

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

Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Orthopaedics. It received FDA 510(k) clearance on 2018-03-19 under 510(k) number K173499. The device is classified under product code JDG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads?

Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads is a medical device that received FDA 510(k) clearance on 2018-03-19. The listed applicant is Stryker Orthopaedics. The 510(k) number is K173499.

When did Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads receive FDA 510(k) clearance?

Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads received FDA 510(k) clearance on 2018-03-19, under 510(k) number K173499.

Who is the listed applicant for Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads?

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

What is the FDA product code for Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads?

The FDA product code for Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads is JDG.

列明Stryker Orthopaedics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。

K211703Insignia髋关节假体 K191414EXETER 中央器，EXETER 2.5mm 插头 K173849铁人三项全膝关节系统 K172326铁人三项全膝关节系统，铁人三项PKR系统，Restoris MCK膝关节系统 K153345Stryker骨科髋部系统标签更新

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