The following data is part of a premarket notification filed by Medtronic Navigation with the FDA for Stealthstation S8 Spine Software V1.0.0.
| Device ID | K170011 |
| 510k Number | K170011 |
| Device Name: | StealthStation S8 Spine Software V1.0.0 |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION 826 COAL CREEK CIRCLE Louisville, CO 80027 |
| Contact | John Connor |
| Correspondent | John Connor MEDTRONIC NAVIGATION 826 COAL CREEK CIRCLE Louisville, CO 80027 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-03 |
| Decision Date | 2017-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169931336 | K170011 | 000 |
| 00763000075842 | K170011 | 000 |
| 00763000075835 | K170011 | 000 |
| 00763000075828 | K170011 | 000 |
| 00763000075811 | K170011 | 000 |
| 00763000075804 | K170011 | 000 |
| 00763000075200 | K170011 | 000 |
| 00763000075149 | K170011 | 000 |
| 00763000242855 | K170011 | 000 |
| 00763000076078 | K170011 | 000 |
| 00763000076085 | K170011 | 000 |
| 00763000076092 | K170011 | 000 |
| 00643169838994 | K170011 | 000 |
| 00763000139193 | K170011 | 000 |
| 00763000125059 | K170011 | 000 |
| 00763000125011 | K170011 | 000 |
| 00763000076214 | K170011 | 000 |
| 00763000076122 | K170011 | 000 |
| 00763000076115 | K170011 | 000 |
| 00763000076108 | K170011 | 000 |
| 00763000242923 | K170011 | 000 |