The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Expedium 4.5mm Spine System.
| Device ID | K073364 |
| 510k Number | K073364 |
| Device Name: | EXPEDIUM 4.5MM 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 | 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 | 2007-11-30 |
| Decision Date | 2008-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034116815 | K073364 | 000 |
| 10705034116716 | K073364 | 000 |
| 10705034116396 | K073364 | 000 |
| 10705034116389 | K073364 | 000 |
| 10705034116310 | K073364 | 000 |
| 10705034116174 | K073364 | 000 |
| 10705034116150 | K073364 | 000 |
| 10705034113685 | K073364 | 000 |
| 10705034113500 | K073364 | 000 |