Clearance Summary
MR8 Drill System, Midas Rex MR8 ClearView Tools received FDA 510(k) clearance under submission number K183515, sponsored by Medtronic Powered Surgical Solutions. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2019-05-12.
- Submission: K183515
- Applicant / Sponsor: Medtronic Powered Surgical Solutions
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4360
- Decision date: 2019-05-12
Classification & Regulation
This clearance is catalogued under FDA product code HBC and 21 CFR 882.4360, within the Neurology review panel as a Class II device.