The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa with the FDA for Cd Horizon Spinal System.
| Device ID | K131321 |
| 510k Number | K131321 |
| Device Name: | CD HORIZON SPINAL SYSTEM |
| Classification | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Applicant | MEDTRONIC SOFAMOR DANEK USA 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lauren Kamer |
| Correspondent | Lauren Kamer MEDTRONIC SOFAMOR DANEK USA 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | OSH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-08 |
| Decision Date | 2013-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169319493 | K131321 | 000 |
| 00643169319486 | K131321 | 000 |
| 00643169319479 | K131321 | 000 |
| 00643169319462 | K131321 | 000 |
| 00643169319455 | K131321 | 000 |
| 00643169319448 | K131321 | 000 |
| 00643169319431 | K131321 | 000 |
| 00643169272262 | K131321 | 000 |
| 00643169272255 | K131321 | 000 |