The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Modification To: Cd Horizon(r) Spinal System.
| Device ID | K101074 |
| 510k Number | K101074 |
| Device Name: | MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Sarah Fairfield |
| Correspondent | Sarah Fairfield 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 |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-19 |
| Decision Date | 2010-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994739438 | K101074 | 000 |
| 00643169007284 | K101074 | 000 |
| 00643169007291 | K101074 | 000 |
| 00643169088481 | K101074 | 000 |
| 00643169088504 | K101074 | 000 |
| 00643169088801 | K101074 | 000 |
| 00643169133709 | K101074 | 000 |
| 00613994739346 | K101074 | 000 |
| 00613994739353 | K101074 | 000 |
| 00613994739360 | K101074 | 000 |
| 00613994739377 | K101074 | 000 |
| 00613994739384 | K101074 | 000 |
| 00613994739391 | K101074 | 000 |
| 00613994739407 | K101074 | 000 |
| 00613994739414 | K101074 | 000 |
| 00613994739421 | K101074 | 000 |
| 00643169007260 | K101074 | 000 |