FDA 510(k)

ZESPIN 髋关节融合系统

K号: K223521 · 2023-01-20

决定日期2023-01-20

产品代码OUR

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

ZESPIN SI Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Aegis Spine, Inc.. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K223521. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ZESPIN SI Joint Fusion System?

ZESPIN SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Aegis Spine, Inc.. The 510(k) number is K223521.

When did ZESPIN SI Joint Fusion System receive FDA 510(k) clearance?

ZESPIN SI Joint Fusion System received FDA 510(k) clearance on 2023-01-20, under 510(k) number K223521.

Who is the listed applicant for ZESPIN SI Joint Fusion System?

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

What is the FDA product code for ZESPIN SI Joint Fusion System?

The FDA product code for ZESPIN SI Joint Fusion System is OUR.

列明Aegis Spine, 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。

K223719牡丹前颈椎板系统，Elatus 腰椎板系统 K221719ABTross ALIF 可扩张笼系统 K221050ZESPIN 骶髂关节融合系统，芍药后路颈椎固定系统，芍药前路颈椎钢板系统，Spinema 腰椎钢板系统 K203531XYPAN可扩张腰椎笼系统

官方来源

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