The following data is part of a premarket notification filed by Medtronic Surgical Navigation Technologies with the FDA for Knee Module For The Stealthstation System.
| Device ID | K012937 |
| 510k Number | K012937 |
| Device Name: | KNEE MODULE FOR THE STEALTHSTATION SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 826 COAL CREEK CIR. Louisville, CO 80027 |
| Contact | Victoria G Rendon |
| Correspondent | Victoria G Rendon 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 | 2001-08-31 |
| Decision Date | 2002-01-25 |
| Summary: | summary |