The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Stealthstation S8 Spine Software V1.3.0.
| Device ID | K201189 |
| 510k Number | K201189 |
| Device Name: | Stealthstation S8 Spine Software V1.3.0 |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Jason Woehrle |
| Correspondent | Jason Woehrle Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80027 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-01 |
| Decision Date | 2020-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000385637 | K201189 | 000 |
| 00763000378240 | K201189 | 000 |
| 00763000377939 | K201189 | 000 |
| 00763000416805 | K201189 | 000 |
| 00763000457204 | K201189 | 000 |