The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Expedium Spine System, Viper System, Viper 2 System.
| Device ID | K111136 |
| 510k Number | K111136 |
| Device Name: | EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Frank Jurczak |
| Correspondent | Frank Jurczak DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-22 |
| Decision Date | 2012-06-14 |
| Summary: | summary |