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 |