The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Eagle Plus Micro Anterior Cervical Plate System.
| Device ID | K080191 |
| 510k Number | K080191 |
| Device Name: | EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Frank S Jurczak |
| Correspondent | Frank S Jurczak DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-25 |
| Decision Date | 2008-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034094601 | K080191 | 000 |
| 10705034094588 | K080191 | 000 |
| 10705034094564 | K080191 | 000 |
| 10705034094540 | K080191 | 000 |
| 10705034094533 | K080191 | 000 |