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 | K153589 |
| 510k Number | K153589 |
| Device Name: | CD HORIZON Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Ankit K. Shah |
| Correspondent | Ankit K. Shah 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 | 2015-12-16 |
| Decision Date | 2016-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169594005 | K153589 | 000 |
| 00643169593916 | K153589 | 000 |
| 00643169593992 | K153589 | 000 |
| 00643169594036 | K153589 | 000 |
| 00643169594012 | K153589 | 000 |
| 00643169593923 | K153589 | 000 |
| 00643169578364 | K153589 | 000 |
| 00643169578371 | K153589 | 000 |
| 00643169578401 | K153589 | 000 |
| 00643169578418 | K153589 | 000 |
| 00643169594029 | K153589 | 000 |
| 00643169594050 | K153589 | 000 |
| 00643169594043 | K153589 | 000 |
| 00643169594067 | K153589 | 000 |