Cleared Traditional

Stealth-Midas System

K160713 · Medtronic Powered Surgical Solutions · Orthopedic
May 2016
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K160713 is an FDA 510(k) clearance for the Stealth-Midas System, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Medtronic Powered Surgical Solutions (Fort Worth, US). The FDA issued a Cleared decision on May 26, 2016, 72 days after receiving the submission on March 15, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K160713 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2016
Decision Date May 26, 2016
Days to Decision 72 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OLO — Orthopedic Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.

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