The following data is part of a premarket notification filed by Vilex, Llc with the FDA for Dynex Ring Fixation System, Diametrix Ring Fixation System.
| Device ID | K202054 |
| 510k Number | K202054 |
| Device Name: | Dynex Ring Fixation System, Diametrix Ring Fixation System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Vilex, LLC 111 Moffitt Street Mcminnville, TN 37110 |
| Contact | Joyce Thacker |
| Correspondent | Joyce Thacker Vilex, LLC 111 Moffitt Street Mcminnville, TN 37110 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-24 |
| Decision Date | 2020-08-24 |
| Summary: | summary |