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 |