The following data is part of a premarket notification filed by Medtronic Surgical Navigation Technologies with the FDA for Medtronic Snt Stealthstation Axiem Imageless Knee Module.
| Device ID | K043088 |
| 510k Number | K043088 |
| Device Name: | MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 826 COAL CREEK CIR. Louisville, CO 80027 |
| Contact | Tina Dreiling |
| Correspondent | Tina Dreiling MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 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 | 2004-11-08 |
| Decision Date | 2005-01-05 |
| Summary: | summary |