The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To Cd Horizon Spinal System.
| Device ID | K043488 |
| 510k Number | K043488 |
| Device Name: | MODIFICATION TO CD HORIZON SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK 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 |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-17 |
| Decision Date | 2005-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994899408 | K043488 | 000 |
| 00613994870605 | K043488 | 000 |
| 00613994870599 | K043488 | 000 |
| 00613994870582 | K043488 | 000 |
| 00613994870575 | K043488 | 000 |
| 00613994870568 | K043488 | 000 |
| 00613994843289 | K043488 | 000 |
| 00613994638694 | K043488 | 000 |
| 00613994350190 | K043488 | 000 |
| 00613994161598 | K043488 | 000 |
| 00613994992536 | K043488 | 000 |
| 00613994870612 | K043488 | 000 |
| 00613994870629 | K043488 | 000 |
| 00613994870636 | K043488 | 000 |
| 00613994870735 | K043488 | 000 |
| 00613994870728 | K043488 | 000 |
| 00613994870711 | K043488 | 000 |
| 00613994870704 | K043488 | 000 |
| 00613994870698 | K043488 | 000 |
| 00613994870681 | K043488 | 000 |
| 00613994870674 | K043488 | 000 |
| 00613994870667 | K043488 | 000 |
| 00613994870650 | K043488 | 000 |
| 00613994870643 | K043488 | 000 |
| 00613994992529 | K043488 | 000 |