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 | K041460 |
| 510k Number | K041460 |
| Device Name: | CD HORIZON SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWQ |
| Subsequent Product Code | KWI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-02 |
| Decision Date | 2004-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074118987 | K041460 | 000 |
| 00885074117904 | K041460 | 000 |
| 00885074118253 | K041460 | 000 |
| 00885074118277 | K041460 | 000 |
| 00885074118307 | K041460 | 000 |
| 00885074118321 | K041460 | 000 |
| 00885074118420 | K041460 | 000 |
| 00885074118666 | K041460 | 000 |
| 00885074118680 | K041460 | 000 |
| 00885074118840 | K041460 | 000 |
| 00885074118888 | K041460 | 000 |
| 00885074118932 | K041460 | 000 |
| 00885074118956 | K041460 | 000 |
| 00885074118970 | K041460 | 000 |
| 00885074117881 | K041460 | 000 |