The following data is part of a premarket notification filed by Vilex, Llc with the FDA for Dynex Micro.
Device ID | K202143 |
510k Number | K202143 |
Device Name: | Dynex Micro |
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 | 2020-07-31 |
Decision Date | 2020-09-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DYNEX MICRO 90267152 not registered Live/Pending |
Vilex LLC 2020-10-20 |