FDA 510(k)

Pisces™-SA 独立 ALIF 椎间系统

K号: K223413 · 2023-02-10

决定日期2023-02-10

产品代码OVD

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

Pisces™-SA STANDALONE ALIF Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Osseus Fusion Systems. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K223413. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pisces™-SA STANDALONE ALIF Interbody System?

Pisces™-SA STANDALONE ALIF Interbody System is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Osseus Fusion Systems. The 510(k) number is K223413.

When did Pisces™-SA STANDALONE ALIF Interbody System receive FDA 510(k) clearance?

Pisces™-SA STANDALONE ALIF Interbody System received FDA 510(k) clearance on 2023-02-10, under 510(k) number K223413.

Who is the listed applicant for Pisces™-SA STANDALONE ALIF Interbody System?

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

What is the FDA product code for Pisces™-SA STANDALONE ALIF Interbody System?

The FDA product code for Pisces™-SA STANDALONE ALIF Interbody System is OVD.

列明Osseus Fusion Systems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。

K222107黑色钻石™ POCT 脊柱系统 K213935PISCES-SA 独立式 ALIF 间体系统 K192495黑色钻石导航仪器 K192121黑色钻石椎弓根螺钉系统

官方来源

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