Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K191597
Stealth Autoguide System, Midas Rex Legend Depth Stop System · Medtronic Navigation, Inc. · decided 2019-11-01 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Stealth Autoguide™ System | 27584 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000205850 |
| Stealth Autoguide™ System | 28324 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000536442 |
| Stealth Autoguide™ System | 28334 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000536404 |
| Stealth Autoguide™ System | 29631 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000362416 |
| Stealth Autoguide™ System | 9736189 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000318321 |
| Midas Rex Legend | ASDS01-R | MEDTRONIC POWERED SURGICAL SOLUTIONS | HBB HBE | 00763000002527 |
| Stealth Autoguide™ System | 28338 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000216689 |
| MIDAS REX LEGEND | DS1TD75 | MEDTRONIC POWERED SURGICAL SOLUTIONS | HBE | 00763000462970 |
| Stealth Autoguide™ System | 9736188 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000318314 |
| Stealth Autoguide™ System | 9736189 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000571856 |
| Midas Rex Legend | DS1TD32L | MEDTRONIC POWERED SURGICAL SOLUTIONS | HBE | 00763000002503 |
| Stealth Autoguide™ System | 28248 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000536343 |
| Stealth Autoguide™ System | 31527 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000536336 |
| Stealth Autoguide™ System | 27563 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000205836 |
| Stealth Autoguide™ System | 31527 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000205881 |
| Stealth Autoguide™ System | 28336 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000215873 |
| Stealth Autoguide™ System | 27565 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000536428 |
| (unnamed) | 9736464 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000650827 |
| Stealth Autoguide™ System | 28248 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000205874 |
| Midas Rex Legend | DS1TD24 | MEDTRONIC POWERED SURGICAL SOLUTIONS | HBE | 00763000002473 |
| Stealth Autoguide™ System | 9736188 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000571849 |
| Stealth Autoguide™ System | 25650 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000536244 |
| Stealth Autoguide™ System | 29480 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000536282 |
| Stealth Autoguide™ System | 28332 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000536459 |
| MIDAS REX LEGEND | DS1TD32L | MEDTRONIC POWERED SURGICAL SOLUTIONS | HBE | 00763000462963 |