Cleared Traditional

ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]

K081475 · Medtronic Xomed, Inc. · Neurology
Oct 2008
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K081475 is an FDA 510(k) clearance for the ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)], a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 17, 2008, 143 days after receiving the submission on May 27, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K081475 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2008
Decision Date October 17, 2008
Days to Decision 143 days
Submission Type Traditional
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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