The following data is part of a premarket notification filed by Amendia, Inc. with the FDA for Diamond Anterior Cervical Plate System.
| Device ID | K100265 |
| 510k Number | K100265 |
| Device Name: | DIAMOND ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | AMENDIA, INC. 1155 ALLGOOD RD. SUITE 6 Marietta, GA 30062 |
| Contact | Tim Lusby |
| Correspondent | Tim Lusby AMENDIA, INC. 1155 ALLGOOD RD. SUITE 6 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 | 2010-01-29 |
| Decision Date | 2010-05-13 |
| Summary: | summary |