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 | K080313 |
| 510k Number | K080313 |
| Device Name: | MODIFICATION TO EXPEDIUM SPINE SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Christopher Klaczyk |
| Correspondent | Christopher Klaczyk DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-06 |
| Decision Date | 2008-05-08 |
| Summary: | summary |