The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Cd Horizon Spinal System.
| Device ID | K143569 |
| 510k Number | K143569 |
| Device Name: | CD HORIZON Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Gregory Maschek |
| Correspondent | Gregory Maschek MEDTRONIC SOFAMOR DANEK USA, 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-16 |
| Decision Date | 2015-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169072640 | K143569 | 000 |
| 00643169207110 | K143569 | 000 |
| 00643169207103 | K143569 | 000 |
| 00643169207035 | K143569 | 000 |
| 00643169207011 | K143569 | 000 |
| 00643169207004 | K143569 | 000 |
| 00643169206779 | K143569 | 000 |
| 00643169206700 | K143569 | 000 |
| 00643169206687 | K143569 | 000 |
| 00643169207127 | K143569 | 000 |
| 00643169207134 | K143569 | 000 |
| 00643169657267 | K143569 | 000 |
| 00643169657243 | K143569 | 000 |
| 00643169657229 | K143569 | 000 |
| 00643169542853 | K143569 | 000 |
| 00643169357792 | K143569 | 000 |
| 00643169352346 | K143569 | 000 |
| 00643169207219 | K143569 | 000 |
| 00643169207141 | K143569 | 000 |
| 00643169206670 | K143569 | 000 |