The following data is part of a premarket notification filed by Johnson & Johnson with the FDA for Expedium Spine System.
| Device ID | K110551 |
| 510k Number | K110551 |
| Device Name: | EXPEDIUM SPINE SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | JOHNSON & JOHNSON 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Frank Jurczak |
| Correspondent | Frank Jurczak JOHNSON & JOHNSON 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 |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-28 |
| Decision Date | 2011-10-26 |
| Summary: | summary |