The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Uniplate Anterior Cervical Plate System.
| Device ID | K042544 |
| 510k Number | K042544 |
| Device Name: | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Sharon Starowicz |
| Correspondent | Sharon Starowicz 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 | 2004-09-20 |
| Decision Date | 2004-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034180762 | K042544 | 000 |
| 10705034180571 | K042544 | 000 |
| 10705034180588 | K042544 | 000 |
| 10705034180595 | K042544 | 000 |
| 10705034180601 | K042544 | 000 |
| 10705034180618 | K042544 | 000 |
| 10705034180625 | K042544 | 000 |
| 10705034180663 | K042544 | 000 |
| 10705034180687 | K042544 | 000 |
| 10705034180694 | K042544 | 000 |
| 10705034180700 | K042544 | 000 |
| 10705034180717 | K042544 | 000 |
| 10705034180755 | K042544 | 000 |
| 10705034180779 | K042544 | 000 |
| 10705034180786 | K042544 | 000 |
| 10705034180793 | K042544 | 000 |
| 10705034180809 | K042544 | 000 |
| 10705034180816 | K042544 | 000 |
| 10705034180564 | K042544 | 000 |