The following data is part of a premarket notification filed by Orthofix, Inc. with the FDA for Azure Anterior Cervical Plate System.
| Device ID | K130825 |
| 510k Number | K130825 |
| Device Name: | AZURE ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ORTHOFIX, INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Contact | Ally Baduel |
| Correspondent | Ally Baduel ORTHOFIX, INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-26 |
| Decision Date | 2013-05-07 |
| Summary: | summary |