Home / Companies / Epic Extremity, LLC

Epic Extremity, LLC

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
5
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1874-2018Class IIEpic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (March 20, 2018
Z-1875-2018Class IIEpic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (March 20, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K182991EPIC Extremity Fusion Plate SystemFebruary 13, 2019
K172441EPIC Extremity Fracture Plate SystemNovember 6, 2017
K163038EPIC Extremity Snap-Off ScrewFebruary 28, 2017
K153340Epic Extremity Plate SystemFebruary 9, 2016
K153333Epic Extremity Cannulated Screw SystemJanuary 19, 2016