The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Cd Horizon Spinal System.
| Device ID | K082236 |
| 510k Number | K082236 |
| Device Name: | CD HORIZON SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 -3576 |
| Contact | Brad Sheals |
| Correspondent | Brad Sheals MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 -3576 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NQP |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-07 |
| Decision Date | 2008-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994484192 | K082236 | 000 |
| 00613994484079 | K082236 | 000 |
| 00613994484062 | K082236 | 000 |
| 00613994484055 | K082236 | 000 |
| 00613994484048 | K082236 | 000 |
| 00613994484031 | K082236 | 000 |
| 00613994484024 | K082236 | 000 |
| 00613994484017 | K082236 | 000 |
| 00613994484000 | K082236 | 000 |
| 00613994483997 | K082236 | 000 |
| 00613994484086 | K082236 | 000 |
| 00613994484093 | K082236 | 000 |
| 00613994484185 | K082236 | 000 |
| 00613994484178 | K082236 | 000 |
| 00613994484161 | K082236 | 000 |
| 00613994484154 | K082236 | 000 |
| 00613994484147 | K082236 | 000 |
| 00613994484130 | K082236 | 000 |
| 00613994484123 | K082236 | 000 |
| 00613994484116 | K082236 | 000 |
| 00613994484109 | K082236 | 000 |
| 00613994483980 | K082236 | 000 |