The following data is part of a premarket notification filed by Medtronic Navigation with the FDA for Stealthstation S8 Cranial V2.0.
| Device ID | K212397 |
| 510k Number | K212397 |
| Device Name: | StealthStation S8 Cranial V2.0 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Carey Brenner |
| Correspondent | Carey Brenner Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-02 |
| Decision Date | 2021-12-22 |