The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Navigated Cd Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps.
| Device ID | K124004 |
| 510k Number | K124004 |
| Device Name: | NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION, INC. 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Michael Blasco |
| Correspondent | Michael Blasco MEDTRONIC NAVIGATION, INC. 826 Coal Creek Circle Louisville, CO 80027 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-03-22 |
| Summary: | summary |