Medtronic Powered Surgical Solutions · Class II · Cleared Nov 23, 2021
| K-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 |
| Applicant | Medtronic Powered Surgical Solutions |
| Product code | HBE |
| Device class | Class II |
| Decision date | Nov 23, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 882.4310 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov