The following data is part of a premarket notification filed by Medtronic Midas Rex with the FDA for Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System Or Legend System.
| Device ID | K020069 |
| 510k Number | K020069 |
| Device Name: | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM |
| Classification | Motor, Drill, Pneumatic |
| Applicant | MEDTRONIC MIDAS REX 4620 NORTH BEACH ST. Fort Worth, TX 76137 |
| Contact | Greg Cannedy |
| Correspondent | Greg Cannedy MEDTRONIC MIDAS REX 4620 NORTH BEACH ST. Fort Worth, TX 76137 |
| Product Code | HBB |
| CFR Regulation Number | 882.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-09 |
| Decision Date | 2002-03-18 |
| Summary: | summary |