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 | K033322 |
| 510k Number | K033322 |
| Device Name: | MODIFICATION TO CD HORIZON SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-15 |
| Decision Date | 2003-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902980053 | K033322 | 000 |
| 00721902979651 | K033322 | 000 |
| 00721902979644 | K033322 | 000 |
| 00721902979637 | K033322 | 000 |
| 00721902979620 | K033322 | 000 |
| 00721902979606 | K033322 | 000 |
| 00721902979590 | K033322 | 000 |
| 00721902979583 | K033322 | 000 |
| 00721902979576 | K033322 | 000 |
| 00721902979545 | K033322 | 000 |
| 00721902979538 | K033322 | 000 |
| 00721902979521 | K033322 | 000 |
| 00721902979514 | K033322 | 000 |
| 00721902979507 | K033322 | 000 |
| 00721902979484 | K033322 | 000 |
| 00721902979477 | K033322 | 000 |
| 00721902979460 | K033322 | 000 |
| 00721902979453 | K033322 | 000 |
| 00721902979668 | K033322 | 000 |
| 00721902979675 | K033322 | 000 |
| 00721902979965 | K033322 | 000 |
| 00721902979958 | K033322 | 000 |
| 00721902979941 | K033322 | 000 |
| 00721902979934 | K033322 | 000 |
| 00721902979910 | K033322 | 000 |
| 00721902979866 | K033322 | 000 |
| 00721902979835 | K033322 | 000 |
| 00721902979828 | K033322 | 000 |
| 00721902979804 | K033322 | 000 |
| 00721902979798 | K033322 | 000 |
| 00721902979781 | K033322 | 000 |
| 00721902979767 | K033322 | 000 |
| 00721902979743 | K033322 | 000 |
| 00721902979712 | K033322 | 000 |
| 00721902979705 | K033322 | 000 |
| 00721902979699 | K033322 | 000 |
| 00721902979682 | K033322 | 000 |
| 00721902979422 | K033322 | 000 |