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 | K102807 |
| 510k Number | K102807 |
| Device Name: | CD HORIZON SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Chris Mckee |
| Correspondent | Chris Mckee 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 | 2010-09-28 |
| Decision Date | 2010-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994846594 | K102807 | 000 |
| 00613994609618 | K102807 | 000 |
| 00613994609601 | K102807 | 000 |
| 00613994609595 | K102807 | 000 |
| 00613994609588 | K102807 | 000 |
| 00613994609571 | K102807 | 000 |
| 00613994609526 | K102807 | 000 |
| 00613994609519 | K102807 | 000 |
| 00613994609502 | K102807 | 000 |
| 00613994609496 | K102807 | 000 |
| 00613994609489 | K102807 | 000 |
| 00613994609472 | K102807 | 000 |
| 00613994609465 | K102807 | 000 |
| 00613994609458 | K102807 | 000 |
| 00613994609625 | K102807 | 000 |
| 00613994609632 | K102807 | 000 |
| 00613994610409 | K102807 | 000 |
| 00613994610393 | K102807 | 000 |
| 00613994610386 | K102807 | 000 |
| 00613994610379 | K102807 | 000 |
| 00613994610362 | K102807 | 000 |
| 00613994610355 | K102807 | 000 |
| 00613994610270 | K102807 | 000 |
| 00613994609694 | K102807 | 000 |
| 00613994609687 | K102807 | 000 |
| 00613994609670 | K102807 | 000 |
| 00613994609663 | K102807 | 000 |
| 00613994609656 | K102807 | 000 |
| 00613994609649 | K102807 | 000 |
| 00613994609441 | K102807 | 000 |