The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Stealthstation System With Cranial Software.
| Device ID | K153660 |
| 510k Number | K153660 |
| Device Name: | StealthStation System With Cranial Software |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Lousville, CO 80027 |
| Contact | Augusta Henao |
| Correspondent | Augusta Henao MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Lousville, 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 | 2015-12-21 |
| Decision Date | 2016-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169625631 | K153660 | 000 |
| 00763000517335 | K153660 | 000 |
| 00763000299927 | K153660 | 000 |
| 00763000299972 | K153660 | 000 |
| 00763000253165 | K153660 | 000 |
| 00763000095741 | K153660 | 000 |
| 00763000095758 | K153660 | 000 |
| 00763000095819 | K153660 | 000 |
| 00643169625532 | K153660 | 000 |
| 00643169625570 | K153660 | 000 |
| 00763000517274 | K153660 | 000 |