The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Modfication To: Expedium Spine System.
| Device ID | K082942 |
| 510k Number | K082942 |
| Device Name: | MODFICATION TO: EXPEDIUM SPINE 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 |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-02 |
| Decision Date | 2008-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034393124 | K082942 | 000 |
| 10705034393117 | K082942 | 000 |
| 10705034393100 | K082942 | 000 |
| 10705034393094 | K082942 | 000 |
| 10705034078168 | K082942 | 000 |
| 10705034295312 | K082942 | 000 |
| 10705034295305 | K082942 | 000 |
| 10705034295299 | K082942 | 000 |