Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Stealth-Midas System

K-Number: K160713 · 2016-05-26

ApplicantMedtronic Powered Surgical Solutions
Decision Date2016-05-26
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stealth-Midas System is a medical device manufactured by Medtronic Powered Surgical Solutions. It received FDA 510(k) clearance on 2016-05-26 under approval number K160713. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stealth-Midas System?

Stealth-Midas System is a medical device that received FDA 510(k) clearance on 2016-05-26. It is manufactured by Medtronic Powered Surgical Solutions. The 510(k) number is K160713.

When was Stealth-Midas System approved by the FDA?

Stealth-Midas System received FDA 510(k) clearance on 2016-05-26, under approval number K160713.

What company makes Stealth-Midas System?

Stealth-Midas System is manufactured by Medtronic Powered Surgical Solutions.

What is the FDA product code for Stealth-Midas System?

The FDA product code for Stealth-Midas System is OLO.

Other Devices by Medtronic Powered Surgical Solutions

K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools 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

View all 7 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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.

↑