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 | K100070 |
| 510k Number | K100070 |
| Device Name: | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Christopher Rogers |
| Correspondent | Christopher Rogers 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 | 2010-01-11 |
| Decision Date | 2010-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034295213 | K100070 | 000 |
| 10705034295190 | K100070 | 000 |
| 10705034295145 | K100070 | 000 |
| 10705034295206 | K100070 | 000 |
| 10705034295183 | K100070 | 000 |
| 10705034295176 | K100070 | 000 |
| 10705034295169 | K100070 | 000 |
| 10705034295152 | K100070 | 000 |