The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Expedium Spine System Spinous Process Fusion Plate.
| Device ID | K050675 |
| 510k Number | K050675 |
| Device Name: | EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Lisa Gilman |
| Correspondent | Lisa Gilman DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-16 |
| Decision Date | 2005-04-11 |
| Summary: | summary |