The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Expedium Anterior Spine System.
| Device ID | K041205 |
| 510k Number | K041205 |
| Device Name: | EXPEDIUM ANTERIOR SPINE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Jennifer Mooney |
| Correspondent | Jennifer Mooney DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-07 |
| Decision Date | 2004-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034138329 | K041205 | 000 |
| 10705034138237 | K041205 | 000 |
| 10705034138244 | K041205 | 000 |
| 10705034138251 | K041205 | 000 |
| 10705034138268 | K041205 | 000 |
| 10705034138275 | K041205 | 000 |
| 10705034138282 | K041205 | 000 |
| 10705034138299 | K041205 | 000 |
| 10705034138305 | K041205 | 000 |
| 10705034138312 | K041205 | 000 |