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 | K152457 |
| 510k Number | K152457 |
| Device Name: | CD HORIZON Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Laveeda Leflore |
| Correspondent | Laveeda Leflore 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 | 2015-08-28 |
| Decision Date | 2015-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169603493 | K152457 | 000 |
| 00643169595118 | K152457 | 000 |
| 00643169595125 | K152457 | 000 |
| 00643169595132 | K152457 | 000 |
| 00643169603387 | K152457 | 000 |
| 00643169603424 | K152457 | 000 |
| 00643169603431 | K152457 | 000 |
| 00643169603448 | K152457 | 000 |
| 00643169603455 | K152457 | 000 |
| 00643169603486 | K152457 | 000 |
| 00643169595101 | K152457 | 000 |