The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Cd Horizon (addition Of Spinous Process Plate).
| Device ID | K032037 |
| 510k Number | K032037 |
| Device Name: | CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-01 |
| Decision Date | 2003-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902962745 | K032037 | 000 |
| 00721902962738 | K032037 | 000 |