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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

K-Number: K170312 · 2017-05-15

ApplicantMedtronic Powered Surgical Solutions
Decision Date2017-05-15
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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 manufactured by Medtronic Powered Surgical Solutions. It received FDA 510(k) clearance on 2017-05-15 under approval number K170312. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Medtronic Powered Surgical Solutions. The 510(k) number is K170312.

When was IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools approved by the FDA?

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 approval number K170312.

What company makes 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 manufactured by Medtronic Powered Surgical Solutions.

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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Related PubMed Literature

PMID: 41613162 Evaluating Translational AI: A Two-Way Moving Target Problem. NEJM AI (2025) PMID: 41543479 Ethical and Regulatory Considerations for Artificial Intelligence Adoption in Craniofacial Surgery. The Journal of craniofacial surgery () PMID: 41529615 Wearable microneedle sensors for continuous interstitial fluid monitoring. Biosensors & bioelectronics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Medtronic Powered Surgical Solutions

K160713Stealth-Midas System K163565MR8 Drill System K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories K183644Stealth-Midas MR8 System K183515MR8 Drill System, Midas Rex MR8 ClearView Tools K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm

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Related Devices (Code: HBC)

K152960ELAN 4 Motor SystemAesculap, Inc. K163565MR8 Drill SystemMedtronic Powered Surgical Solutions K173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions K193630hekaDrillZethon, Ltd. K213697ORiGO SystemBien-Air Surgery SA

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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