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 | K140449 |
| 510k Number | K140449 |
| Device Name: | CD HORIZON SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Gregory Maschek |
| Correspondent | Gregory Maschek 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 | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-24 |
| Decision Date | 2014-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169377585 | K140449 | 000 |
| 00643169377424 | K140449 | 000 |
| 00643169377431 | K140449 | 000 |
| 00643169377448 | K140449 | 000 |
| 00643169377455 | K140449 | 000 |
| 00643169377462 | K140449 | 000 |
| 00643169377479 | K140449 | 000 |
| 00643169377486 | K140449 | 000 |
| 00643169377493 | K140449 | 000 |
| 00643169377509 | K140449 | 000 |
| 00643169377516 | K140449 | 000 |
| 00643169377523 | K140449 | 000 |
| 00643169377530 | K140449 | 000 |
| 00643169377547 | K140449 | 000 |
| 00643169377554 | K140449 | 000 |
| 00643169377561 | K140449 | 000 |
| 00643169377578 | K140449 | 000 |
| 00643169377417 | K140449 | 000 |