510(k) K183515
K183515 is an FDA 510(k) premarket notification submitted by Medtronic Powered Surgical Solutions for the device "MR8 Drill System, Midas Rex MR8 ClearView Tools". The FDA issued a decision of Substantially Equivalent on May 12, 2019. The device falls under product code HBC (Motor, Drill, Electric), a Class II device regulated under 21 CFR 882.4360. Medtronic Powered Surgical Solutions has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 2019
- Date Received
- December 18, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Drill, Electric
- Device Class
- Class II
- Regulation Number
- 882.4360
- Review Panel
- NE
- Submission Type