The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Imageless Hip Module For The Stealthstation System.
| Device ID | K052623 |
| 510k Number | K052623 |
| Device Name: | IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Lousville, CO 80027 |
| Contact | Tina Dreiling |
| Correspondent | Tina Dreiling MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Lousville, CO 80027 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-23 |
| Decision Date | 2006-03-02 |
| Summary: | summary |