Cleared Traditional

Stealth-Midas MR8 System

K183644 · Medtronic Powered Surgical Solutions · Orthopedic
May 2019
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K183644 is an FDA 510(k) clearance for the Stealth-Midas MR8 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 22, 2019, 147 days after receiving the submission on December 26, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K183644 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2018
Decision Date May 22, 2019
Days to Decision 147 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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