Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K162309
StealthStation S8 System Platforms and StealthStation Cranial Software · Medtronic Navigation, Inc. · decided 2017-03-31 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| StealthStation S8 Platform | 9735668 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000359935 |
| Stealth S8 | 9735957 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000533076 |
| StealthStation S8 Platform | 9735665 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000272760 |
| StealthStation | 9736025 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000075255 |
| StealthStation S8 | 9735960 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000533090 |
| Stealth S8 | 9735959 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000533083 |
| StealthStation Cranial Software | 9735916 | MEDTRONIC NAVIGATION, INC. | HAW | 00643169931329 |
| (unnamed) | 9735547ENT | MEDTRONIC NAVIGATION, INC. | HAW | 00763000632779 |
| StealthStation S8 Platform | 9735666 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000360382 |
| StealthStation S8 | 9735665 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000359874 |
| StealthStation Cranial Software | 9735739 | MEDTRONIC NAVIGATION, INC. | HAW | 00643169838987 |
| (unnamed) | 9736023 | MEDTRONIC NAVIGATION, INC. | HAW | 00643169966963 |
| (unnamed) | 9735547ENT | MEDTRONIC NAVIGATION, INC. | HAW | 00763000385552 |
| StealthStation | 9735916 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000234683 |
| StealthStation S8 | 9735667 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000359775 |
| StealthStation | 9735918 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000125042 |
| StealthStation S8 | 9735670 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000355128 |
| StealthStation | 9736025 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000075286 |
| (unnamed) | 9733752R | MEDTRONIC NAVIGATION, INC. | HAW | 00763000972318 |
| StealthStation S8 Platform | 9735665 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000272739 |
| StealthStation Cranial Software | 9735739 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000238650 |
| StealthStation S8 Platform | 9735669 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000360467 |
| Medtronic | 9735669R | MEDTRONIC NAVIGATION, INC. | HAW | 00763000401184 |
| StealthStation S8 | 9735918 | MEDTRONIC NAVIGATION, INC. | HAW | 00643169921924 |
| (unnamed) | 9735894 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000423179 |