The following data is part of a premarket notification filed by Medynus Inc. with the FDA for Impeace And Impeace-uni Anterior Cervical Plate System.
| Device ID | K220379 |
| 510k Number | K220379 |
| Device Name: | IMPEACE And IMPEACE-Uni Anterior Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Medynus Inc. 18 Technology Dr. Ste 109 Irvine, CA 92618 |
| Contact | David Shin |
| Correspondent | Jeena Mathai Eerkie Corporation 4027 Runnymeade Dr Collegeville, PA 19426 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-10 |
| Decision Date | 2022-03-03 |