The following data is part of a premarket notification filed by Orthofix, Inc. with the FDA for Azure Anterior Cervical Plate System.
| Device ID | K143028 |
| 510k Number | K143028 |
| Device Name: | Azure Anterior Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ORTHOFIX, INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Contact | Natalia Volosen |
| Correspondent | Natalia Volosen ORTHOFIX, INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-21 |
| Decision Date | 2015-05-29 |