The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Cd Horizon Spinal System.
| Device ID | K993810 |
| 510k Number | K993810 |
| Device Name: | CD HORIZON SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne DANEK MEDICAL, INC. 1800 PYRAMID PL. 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-10 |
| Decision Date | 2000-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994268808 | K993810 | 000 |
| 00673978058825 | K993810 | 000 |
| 00673978058818 | K993810 | 000 |
| 00673978058801 | K993810 | 000 |
| 00673978058795 | K993810 | 000 |
| 00673978058788 | K993810 | 000 |
| 00673978058771 | K993810 | 000 |
| 00673978058764 | K993810 | 000 |
| 00673978051413 | K993810 | 000 |
| 00673978051215 | K993810 | 000 |
| 00721902303906 | K993810 | 000 |
| 00673978058832 | K993810 | 000 |
| 00673978058849 | K993810 | 000 |
| 00613994268792 | K993810 | 000 |
| 00673978058948 | K993810 | 000 |
| 00673978058924 | K993810 | 000 |
| 00673978058917 | K993810 | 000 |
| 00673978058900 | K993810 | 000 |
| 00673978058894 | K993810 | 000 |
| 00673978058887 | K993810 | 000 |
| 00673978058870 | K993810 | 000 |
| 00673978058863 | K993810 | 000 |
| 00673978058856 | K993810 | 000 |
| 00885074468259 | K993810 | 000 |