Cleared Special

MIDAS REX CURVED BUR

K072315 · Medtronic Powered Surgical Solutions · Neurology
Sep 2007
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K072315 is an FDA 510(k) clearance for the MIDAS REX CURVED BUR, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by Medtronic Powered Surgical Solutions (Fort Worth, US). The FDA issued a Cleared decision on September 18, 2007, 29 days after receiving the submission on August 20, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K072315 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 2007
Decision Date September 18, 2007
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBE — Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4310

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