The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Eagle Anterior Cervial Plate System.
| Device ID | K040197 |
| 510k Number | K040197 |
| Device Name: | EAGLE ANTERIOR CERVIAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Lisa Gilman |
| Correspondent | Lisa Gilman DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-29 |
| Decision Date | 2004-04-02 |
| Summary: | summary |