The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System.
| Device ID | K133444 |
| 510k Number | K133444 |
| Device Name: | STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIR. Louisville, CO 80027 |
| Contact | Kaye Waite |
| Correspondent | Kaye Waite MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIR. 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 | 2013-11-12 |
| Decision Date | 2014-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000769208 | K133444 | 000 |