The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Cd Horizon Spinal System.
| Device ID | K142591 |
| 510k Number | K142591 |
| Device Name: | CD HORIZON Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lila Joe |
| Correspondent | Lila Joe MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-15 |
| Decision Date | 2014-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169429062 | K142591 | 000 |
| 00763000802134 | K142591 | 000 |
| 00763000794682 | K142591 | 000 |
| 00763000794668 | K142591 | 000 |
| 00763000794620 | K142591 | 000 |
| 00763000794606 | K142591 | 000 |
| 00763000794576 | K142591 | 000 |
| 00763000794521 | K142591 | 000 |
| 00763000794491 | K142591 | 000 |
| 00763000794460 | K142591 | 000 |
| 00763000794453 | K142591 | 000 |
| 00643169428607 | K142591 | 000 |
| 00643169428836 | K142591 | 000 |
| 00643169428560 | K142591 | 000 |
| 00643169428959 | K142591 | 000 |
| 00643169428928 | K142591 | 000 |
| 00643169428898 | K142591 | 000 |
| 00643169428812 | K142591 | 000 |
| 00643169428775 | K142591 | 000 |
| 00643169428751 | K142591 | 000 |
| 00643169428720 | K142591 | 000 |
| 00643169428676 | K142591 | 000 |
| 00643169428645 | K142591 | 000 |
| 00643169428614 | K142591 | 000 |
| 00763000794415 | K142591 | 000 |