The following data is part of a premarket notification filed by Medtronic Powered Surgical Solutions with the FDA for Mr8 Drill System, Midas Rex Mr8 Clearview Tools.
| Device ID | K183515 |
| 510k Number | K183515 |
| Device Name: | MR8 Drill System, Midas Rex MR8 ClearView Tools |
| Classification | Motor, Drill, Electric |
| Applicant | Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, TX 76137 |
| Contact | Jenna Groves |
| Correspondent | Jenna Groves Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, TX 76137 |
| Product Code | HBC |
| Subsequent Product Code | ERL |
| Subsequent Product Code | HBB |
| Subsequent Product Code | HBE |
| Subsequent Product Code | HSZ |
| CFR Regulation Number | 882.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-18 |
| Decision Date | 2019-05-12 |