The following data is part of a premarket notification filed by Depuy Spine, A Johnson & Johnson Company with the FDA for Expedium 4.5mm Spine System.
| Device ID | K071495 |
| 510k Number | K071495 |
| Device Name: | EXPEDIUM 4.5MM SPINE SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | DEPUY SPINE, A JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Contact | Christopher Klaczyk |
| Correspondent | Christopher Klaczyk DEPUY SPINE, A JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-31 |
| Decision Date | 2007-06-29 |
| Summary: | summary |