FDA 510(k)

BonOs HV Genta，BonOs MV Genta，BonOs LV Genta

K号: K210125 · 2021-03-19

决定日期2021-03-19

产品代码LOD

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

BonOs HV Genta, BonOs MV Genta, BonOs LV Genta is the device name listed in this FDA 510(k) record. The listed applicant is Osartis GmbH. It received FDA 510(k) clearance on 2021-03-19 under 510(k) number K210125. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BonOs HV Genta, BonOs MV Genta, BonOs LV Genta?

BonOs HV Genta, BonOs MV Genta, BonOs LV Genta is a medical device that received FDA 510(k) clearance on 2021-03-19. The listed applicant is Osartis GmbH. The 510(k) number is K210125.

When did BonOs HV Genta, BonOs MV Genta, BonOs LV Genta receive FDA 510(k) clearance?

BonOs HV Genta, BonOs MV Genta, BonOs LV Genta received FDA 510(k) clearance on 2021-03-19, under 510(k) number K210125.

Who is the listed applicant for BonOs HV Genta, BonOs MV Genta, BonOs LV Genta?

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

What is the FDA product code for BonOs HV Genta, BonOs MV Genta, BonOs LV Genta?

The FDA product code for BonOs HV Genta, BonOs MV Genta, BonOs LV Genta is LOD.

列明Osartis GmbH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。

K240856髋关节间隙模具；膝关节间隙模具；肩关节间隙模具 K202458BonOs注射，椎弓根螺钉套装，水泥推进器 K210120BonOs HV，BonOs MV，BonOs LV K192394Hi-Fatigue Bone Cement K192379Hi-Fatigue G Bone Cement

官方来源

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