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 | K000641 |
| 510k Number | K000641 |
| Device Name: | CD HORIZON SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-25 |
| Decision Date | 2000-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978973616 | K000641 | 000 |
| 00763000027988 | K000641 | 000 |
| 00721902375507 | K000641 | 000 |
| 00721902375514 | K000641 | 000 |
| 00721902375521 | K000641 | 000 |
| 00721902375538 | K000641 | 000 |
| 00721902375569 | K000641 | 000 |
| 00721902375606 | K000641 | 000 |
| 00721902988691 | K000641 | 000 |
| 00721902988707 | K000641 | 000 |
| 00673978809519 | K000641 | 000 |
| 00763000875916 | K000641 | 000 |