Clearance Summary
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] received FDA 510(k) clearance under submission number K081475, sponsored by Medtronic Xomed, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2008-10-17.
- Submission: K081475
- Applicant / Sponsor: Medtronic Xomed, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4310
- Decision date: 2008-10-17
Classification & Regulation
This clearance is catalogued under FDA product code HBE and 21 CFR 882.4310, within the Neurology review panel as a Class II device.