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FDA 510(k)

ZESPIN 骶髂关节融合系统，MegaCerfix 后路颈椎固定系统，MegaCerfix 前路颈椎钢板系统，Spinema 腰椎钢板系统

K号: K210035 · 2021-02-16

申请人Aegis Spine
决定日期2021-02-16
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, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Aegis Spine. It received FDA 510(k) clearance on 2021-02-16 under 510(k) number K210035. 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, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System?

ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2021-02-16. The listed applicant is Aegis Spine. The 510(k) number is K210035.

When did ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System receive FDA 510(k) clearance?

ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System received FDA 510(k) clearance on 2021-02-16, under 510(k) number K210035.

Who is the listed applicant for ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System?

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

What is the FDA product code for ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System?

The FDA product code for ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System is OUR.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：OUR）

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。

K261381TiLink-L™ 髋关节融合系统SurGenTec, LLCK260477CATAMARAN™髋关节融合系统Tenon MedicalK253488iFuse INTRA Ti™植入系统SI-BONE, Inc.K253611Falco 融合系统Mcnicoll Surgical, Inc.K252834骶髂关节支架系统（SJTS）4Web MedicalK251365OptumSI 嵌入系统Si Solutions, LLC

官方来源

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