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

Substantially Equivalent

Medtronic Xomed, Inc.

FDA 510(k) clearance K081475 for ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)], Substantially Equivalent on 2008-10-17. Applicant: Medtronic Xomed, Inc..

Clearance details

Applicant: Medtronic Xomed, Inc.
Product code: Code HBE
Advisory panel: Neurology
Date received: 2008-05-27
Decision date: 2008-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.