The following data is part of a premarket notification filed by Amendia, Inc with the FDA for Amendia Cervical Plate System.
| Device ID | K152455 |
| 510k Number | K152455 |
| Device Name: | Amendia Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Amendia, Inc 1755 West Oak Parkway Marietta, GA 30062 |
| Contact | Kristen Allen |
| Correspondent | Kristen Allen Amendia, Inc 1755 West Oak Parkway Marietta, GA 30062 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-28 |
| Decision Date | 2015-10-15 |
| Summary: | summary |