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FDA 510(k)

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

Número K: K170312 · 2017-05-15

RequerenteMedtronic Powered Surgical Solutions
Data da decisão2017-05-15
Código do produtoHBC
Comité consultivoNE
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Dispositivos Relacionados (Código: HBC)

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K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.K233153Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd.K232938Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd.K213697ORiGO SystemBien-Air Surgery SAK220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc.K193630hekaDrillZethon, Ltd.

Fonte oficial

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