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 | K121764 |
| 510k Number | K121764 |
| Device Name: | CD HORIZON SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Brad Sheals |
| Correspondent | Brad Sheals 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 | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-15 |
| Decision Date | 2012-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169118591 | K121764 | 000 |
| 00643169156722 | K121764 | 000 |
| 00643169156715 | K121764 | 000 |
| 00643169156708 | K121764 | 000 |
| 00643169156692 | K121764 | 000 |
| 00643169156685 | K121764 | 000 |
| 00643169156678 | K121764 | 000 |
| 00643169156661 | K121764 | 000 |
| 00643169156654 | K121764 | 000 |
| 00643169156647 | K121764 | 000 |
| 00643169156630 | K121764 | 000 |
| 00643169156623 | K121764 | 000 |
| 00643169156616 | K121764 | 000 |
| 00643169156609 | K121764 | 000 |
| 00643169156593 | K121764 | 000 |
| 00643169156586 | K121764 | 000 |
| 00643169156579 | K121764 | 000 |
| 00643169156562 | K121764 | 000 |
| 00643169156739 | K121764 | 000 |
| 00643169156746 | K121764 | 000 |
| 00643169118584 | K121764 | 000 |
| 00643169118577 | K121764 | 000 |
| 00643169156890 | K121764 | 000 |
| 00643169156883 | K121764 | 000 |
| 00643169156876 | K121764 | 000 |
| 00643169156869 | K121764 | 000 |
| 00643169156852 | K121764 | 000 |
| 00643169156845 | K121764 | 000 |
| 00643169156838 | K121764 | 000 |
| 00643169156821 | K121764 | 000 |
| 00643169156814 | K121764 | 000 |
| 00643169156807 | K121764 | 000 |
| 00643169156791 | K121764 | 000 |
| 00643169156784 | K121764 | 000 |
| 00643169156777 | K121764 | 000 |
| 00643169156760 | K121764 | 000 |
| 00643169156753 | K121764 | 000 |
| 00643169156555 | K121764 | 000 |