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FDA 510(k)

IPC系统，Legend EHS手柄和Legend Stylus Touch手柄，Microsaw手柄，Triton电动高扭矩手柄，附件和外科解剖工具

K号: K170312 · 2017-05-15

申请人Medtronic Powered Surgical Solutions
决定日期2017-05-15
产品代码HBC
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Powered Surgical Solutions. It received FDA 510(k) clearance on 2017-05-15 under 510(k) number K170312. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools?

IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools is a medical device that received FDA 510(k) clearance on 2017-05-15. The listed applicant is Medtronic Powered Surgical Solutions. The 510(k) number is K170312.

When did IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools receive FDA 510(k) clearance?

IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools received FDA 510(k) clearance on 2017-05-15, under 510(k) number K170312.

Who is the listed applicant for IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools?

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

What is the FDA product code for IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools?

The FDA product code for IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools is HBC.

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 Powered Surgical Solutions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。

K213454Midas Rex MR8 深度停止配件，Midas Rex MR8 深度停止工具 2.4mm，Midas Rex MR8 深度停止工具 3.2mm，Midas Rex MR8 深度停止工具 3.2mm 长，Midas Rex MR8 深度停止工具 7.5mmK183644Stealth-Midas MR8系统K183515MR8 钻孔系统，Midas Rex MR8 ClearView 工具K163565MR8 钻孔系统K163182Medtronic Legend 气动；MR7 气动；Triton 气动钻机系统，包括各种气动手柄；附件；外科解剖工具；以及系统附件K160713Stealth-Midas系统

查看所有 7 个设备 →

相关器械（代码：HBC）

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。

K254174手术动力系统Guizhou Zirui Technology Co., Ltd.K233153Traus SSG10 手术系统Saeshin Precision Co., Ltd.K232938Traus SSG30 手术系统Saeshin Precision Co., Ltd.K213697ORiGO 系统Bien-Air Surgery SAK220485无线手控装置，EG1A（WIRELESS-HC），无线手控装置接收器，EG1A（RECEIVER-HC）The Anspach Effort, Inc.K193630hekaDrillZethon, 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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