The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Navigated Cd Horizon Solera Screwdriver/taps.
| Device ID | K140454 |
| 510k Number | K140454 |
| Device Name: | NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Regina Holmes |
| Correspondent | Regina Holmes MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-24 |
| Decision Date | 2014-05-22 |
| Summary: | summary |