The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Cardiff Anterior Cervical Plate System.
| Device ID | K083338 |
| 510k Number | K083338 |
| Device Name: | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862 |
| Contact | Ethel Bernal |
| Correspondent | Ethel Bernal SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-12 |
| Decision Date | 2009-02-02 |
| Summary: | summary |