The following data is part of a premarket notification filed by Medtronic Powered Surgical Solutions with the FDA for Midas Rex Curved Bur.
| Device ID | K072315 |
| 510k Number | K072315 |
| Device Name: | MIDAS REX CURVED BUR |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | MEDTRONIC POWERED SURGICAL SOLUTIONS 4620 NORTH BEACH ST. Fort Worth, TX 76137 |
| Contact | Jeffrey Henderson |
| Correspondent | Jeffrey Henderson MEDTRONIC POWERED SURGICAL SOLUTIONS 4620 NORTH BEACH ST. Fort Worth, TX 76137 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-20 |
| Decision Date | 2007-09-18 |
| Summary: | summary |