The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Cd Horizon Spinal System.
| Device ID | K111510 |
| 510k Number | K111510 |
| Device Name: | CD HORIZON SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Kevin Ford |
| Correspondent | Kevin Ford MEDTRONIC SOFAMOR DANEK, 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 | NQP |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-01 |
| Decision Date | 2011-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994929525 | K111510 | 000 |
| 00613994929402 | K111510 | 000 |
| 00613994929396 | K111510 | 000 |
| 00613994929389 | K111510 | 000 |
| 00613994929372 | K111510 | 000 |
| 00613994929365 | K111510 | 000 |
| 00613994929358 | K111510 | 000 |
| 00613994929341 | K111510 | 000 |
| 00613994929334 | K111510 | 000 |
| 00613994929327 | K111510 | 000 |
| 00613994929419 | K111510 | 000 |
| 00613994929426 | K111510 | 000 |
| 00613994929518 | K111510 | 000 |
| 00613994929501 | K111510 | 000 |
| 00613994929495 | K111510 | 000 |
| 00613994929488 | K111510 | 000 |
| 00613994929471 | K111510 | 000 |
| 00613994929464 | K111510 | 000 |
| 00613994929457 | K111510 | 000 |
| 00613994929440 | K111510 | 000 |
| 00613994929433 | K111510 | 000 |
| 00613994929310 | K111510 | 000 |