K213454 is an FDA 510(k) clearance for the 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. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).
Submitted by Medtronic Powered Surgical Solutions (Fort Worth, US). The FDA issued a Cleared decision on November 23, 2021, 28 days after receiving the submission on October 26, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.
| 510(k) Number | K213454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2021 |
| Decision Date | November 23, 2021 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBE - Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4310 |