The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Modification To Expedium Spine System.
| Device ID | K062174 |
| 510k Number | K062174 |
| Device Name: | MODIFICATION TO EXPEDIUM SPINE SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Mary Gray |
| Correspondent | Mary Gray DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-31 |
| Decision Date | 2006-11-02 |
| Summary: | summary |