Cleared Traditional

K081475 - ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] (FDA 510(k) Clearance)

K081475 · Medtronic Xomed, Inc. · Neurology device

Oct 2008

Decision

143d

Days

Class 2

Risk

K081475 is an FDA 510(k) clearance for the ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]. This device is classified as 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 FDA review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K081475 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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