The following data is part of a premarket notification filed by Medtronic Powered Surgical Solutions with the FDA for Midas Rex Mr7 Pneumatic High Speed System, Models Pm700, Pm710, Pc700, Pc710, Pc720, Pa700.
| Device ID | K090112 |
| 510k Number | K090112 |
| Device Name: | MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 |
| Classification | Motor, Drill, Pneumatic |
| Applicant | MEDTRONIC POWERED SURGICAL SOLUTIONS 4620 NORTH BEACH ST. Fort Worth, TX 76137 |
| Contact | Jeffery Henderson |
| Correspondent | Jeffery Henderson MEDTRONIC POWERED SURGICAL SOLUTIONS 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 | 2009-01-16 |
| Decision Date | 2009-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994612205 | K090112 | 000 |
| 00643169672499 | K090112 | 000 |
| 00763000182069 | K090112 | 000 |
| 00763000182052 | K090112 | 000 |
| 00763000181994 | K090112 | 000 |
| 00763000176242 | K090112 | 000 |
| 00763000174835 | K090112 | 000 |
| 00763000174828 | K090112 | 000 |
| 00763000096786 | K090112 | 000 |
| 00763000096731 | K090112 | 000 |
| 20763000010328 | K090112 | 000 |
| 20613994486206 | K090112 | 000 |
| 00763000337445 | K090112 | 000 |
| 00763000337438 | K090112 | 000 |
| 00763000337421 | K090112 | 000 |
| 00763000431006 | K090112 | 000 |
| 00643169672505 | K090112 | 000 |
| 00643169672512 | K090112 | 000 |
| 00643169672529 | K090112 | 000 |
| 00613994601544 | K090112 | 000 |
| 00613994601537 | K090112 | 000 |
| 00613994503794 | K090112 | 000 |
| 00613994503787 | K090112 | 000 |
| 00613994503770 | K090112 | 000 |
| 00613994486257 | K090112 | 000 |
| 00613994486240 | K090112 | 000 |
| 00613994486233 | K090112 | 000 |
| 00613994486226 | K090112 | 000 |
| 00613994486219 | K090112 | 000 |
| 00613994486196 | K090112 | 000 |
| 00613994486172 | K090112 | 000 |
| 00613994486165 | K090112 | 000 |
| 00613994486158 | K090112 | 000 |
| 00643169933804 | K090112 | 000 |
| 00763000430986 | K090112 | 000 |