The following data is part of a premarket notification filed by Vilex In Tennessee, Inc with the FDA for X-fix Line Additions.
Device ID | K151881 |
510k Number | K151881 |
Device Name: | X-Fix Line Additions |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | VILEX IN TENNESSEE, INC 111 MOFFITT STREET Mcminnville, TN 37110 |
Contact | Sylvia Southard |
Correspondent | Abraham Lavi VILEX, INC. 8374 MARKET STREET, #167 Lakewood Ranch, FL 34202 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-09 |
Decision Date | 2016-03-24 |
Summary: | summary |