The following data is part of a premarket notification filed by Medtronic Powered Surgical Solutions with the FDA for Midas Rex Mr8 Depth Stop Attachment, Midas Rex Mr8 Depth Stop Tool 2.4mm, Midas Rex Mr8 Depth Stop Tool 3.2mm, Midas Rex Mr8 Depth Stop Tool 3.2mm Long, Midas Rex Mr8 Depth Stop Tool 7.5mm.
| Device ID | K213454 |
| 510k Number | K213454 |
| Device Name: | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, TX 76137 |
| Contact | Carrie Eddings |
| Correspondent | Carrie Eddings Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, TX 76137 |
| Product Code | HBE |
| Subsequent Product Code | HBB |
| Subsequent Product Code | HBC |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-26 |
| Decision Date | 2021-11-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000595302 | K213454 | 000 |
| 00763000521639 | K213454 | 000 |
| 00763000521646 | K213454 | 000 |
| 00763000521653 | K213454 | 000 |
| 00763000521660 | K213454 | 000 |
| 00763000595258 | K213454 | 000 |
| 00763000595272 | K213454 | 000 |
| 00763000595289 | K213454 | 000 |
| 00763000595296 | K213454 | 000 |
| 00763000521615 | K213454 | 000 |