The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Modification To Cd Horizon Spinal System.
| Device ID | K063083 |
| 510k Number | K063083 |
| Device Name: | MODIFICATION TO CD HORIZON SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Edward S Chin |
| Correspondent | Edward S Chin MEDTRONIC SOFAMOR DANEK, INC. 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 |
| Subsequent Product Code | NQP |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-10 |
| Decision Date | 2006-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994198242 | K063083 | 000 |
| 00613994197696 | K063083 | 000 |
| 00613994197689 | K063083 | 000 |
| 00613994197511 | K063083 | 000 |
| 00613994197504 | K063083 | 000 |
| 00613994197498 | K063083 | 000 |
| 00613994197429 | K063083 | 000 |
| 00613994197412 | K063083 | 000 |
| 00613994197405 | K063083 | 000 |
| 00613994197399 | K063083 | 000 |
| 00613994197382 | K063083 | 000 |
| 00613994197375 | K063083 | 000 |
| 00613994197368 | K063083 | 000 |
| 00613994197702 | K063083 | 000 |
| 00613994197719 | K063083 | 000 |
| 00613994197832 | K063083 | 000 |
| 00613994197825 | K063083 | 000 |
| 00613994197818 | K063083 | 000 |
| 00613994197801 | K063083 | 000 |
| 00613994197795 | K063083 | 000 |
| 00613994197788 | K063083 | 000 |
| 00613994197771 | K063083 | 000 |
| 00613994197764 | K063083 | 000 |
| 00613994197757 | K063083 | 000 |
| 00613994197740 | K063083 | 000 |
| 00613994197733 | K063083 | 000 |
| 00613994197726 | K063083 | 000 |
| 00613994197344 | K063083 | 000 |