The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Stylet, 23cm, Skull-mount Patient Tracker, Non-invasive Patient Tracker, Tracer Pointer, Touch-n-go Pointer, Navigation.
| Device ID | K141833 |
| 510k Number | K141833 |
| Device Name: | STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION, INC. 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Christopher Perman |
| Correspondent | Christopher Perman MEDTRONIC NAVIGATION, INC. 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 | 2014-07-07 |
| Decision Date | 2015-03-25 |
| Summary: | summary |