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 | K063417 |
| 510k Number | K063417 |
| Device Name: | MODIFICATION TO CD HORIZON SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lee Grant |
| Correspondent | Lee Grant MEDTRONIC SOFAMOR DANEK 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 | 2006-11-13 |
| Decision Date | 2007-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994235619 | K063417 | 000 |
| 00763000681449 | K063417 | 000 |
| 00763000681456 | K063417 | 000 |
| 00763000681463 | K063417 | 000 |
| 00763000681470 | K063417 | 000 |
| 00613994234605 | K063417 | 000 |
| 00613994235589 | K063417 | 000 |
| 00613994235596 | K063417 | 000 |
| 00613994235602 | K063417 | 000 |
| 00763000681432 | K063417 | 000 |