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FDA 510(k)

KYPHON HV-R带孔螺钉水泥，CD HORIZON带孔螺钉套装

K号: K152604 · 2016-01-06

申请人Medtronic Sofamor Danek USA, Incorporated
决定日期2016-01-06
产品代码PML
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

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Incorporated. It received FDA 510(k) clearance on 2016-01-06 under 510(k) number K152604. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set?

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Medtronic Sofamor Danek USA, Incorporated. The 510(k) number is K152604.

When did KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set receive FDA 510(k) clearance?

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set received FDA 510(k) clearance on 2016-01-06, under 510(k) number K152604.

Who is the listed applicant for KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set?

The FDA product code for KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set is PML.

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：PML）

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。

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官方来源

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