The following data is part of a premarket notification filed by Met One Technologies with the FDA for Met One Czar Anterior Cervical Plate System.
| Device ID | K180772 |
| 510k Number | K180772 |
| Device Name: | Met One Czar Anterior Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Met One Technologies 154 N. Festival Dr. Villa F El Paso, TX 79912 |
| Contact | Evan Carbonell |
| Correspondent | Daniel Johnson JALEX Medical, LLC. 30311 Clemens Rd. Suite 5D Westlake, OH 44145 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-23 |
| Decision Date | 2018-12-17 |
| Summary: | summary |