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FDA 510(k)

CD HORIZON®脊柱系统，Medtronic可重复使用工具，用于IPC® POWEREASE®系统，Medtronic导航可重复使用工具，用于STEALTHSTATION®和IPC® POWEREASE®系统

K号: K170679 · 2017-05-11

申请人Medtronic Sofamor Danek
决定日期2017-05-11
产品代码NKB
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

CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2017-05-11 under 510(k) number K170679. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems?

CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems is a medical device that received FDA 510(k) clearance on 2017-05-11. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K170679.

When did CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems receive FDA 510(k) clearance?

CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems received FDA 510(k) clearance on 2017-05-11, under 510(k) number K170679.

Who is the listed applicant for CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems?

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

What is the FDA product code for CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems?

The FDA product code for CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems is NKB.

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

列明Medtronic Sofamor Danek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。

K212428Centerpiece板固定系统K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyK173125T2 STRATOSPHERE™ Expandable Corpectomy SystemK172199ELEVATE 脊柱系统，CAPSTONE PTC 脊柱系统，CRESCENT 脊柱系统，CRESCENT 脊柱系统钛合金K171031CRESCENT™ 脊柱系统K171468FUSE 脊柱系统

查看所有 9 个设备 →

相关器械（代码：NKB）

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。

K252139肯特罗斯宾 Viktr-MIS® 椎弓根螺钉系统Rivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™植入系统SI-BONE, Inc.K262091FRAXION 脊柱固定系统Ortler Global Tibbi Gerecler Anonim SirketiK262193RIVA® 后固定系统，配备NanoACTIV表面技术；RIVA® 锚定骶髂固定系统，配备NanoACTIV表面技术Xenix MedicalK262828KHEIRON®脊柱固定系统，包括患者专用K-RODS.M.A.I.OK260362QUATTRO脊柱系统（开放配置）；QUATTRO-GADGET脊柱系统（微创配置）MANTIZ Co., Ltd.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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