U&I Corporation

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K220147Aspiron S ACP SystemFebruary 16, 2022
K210573Velofix SA Cervical CageNovember 19, 2021
K183243Velofix TLIF CageJuly 10, 2019
K190067Velofix Interbody Fusion SystemFebruary 4, 2019
K190053SECULOK™ ACP SystemFebruary 1, 2019
K181824CBT Screw Fixation SystemDecember 13, 2018
K183383ANAX™ OCT Spinal SystemDecember 12, 2018
K181829Velofix TLIF CageNovember 14, 2018
K182055SECULOK™ ACP SystemSeptember 10, 2018
K180759SECULOK™ Suture AnchorAugust 9, 2018
K173198Facet Screw Fixation SystemJanuary 3, 2018
K173524ANAX 5.5™ Spinal SystemDecember 13, 2017
K172419Velofix™ TLIF CageDecember 4, 2017
K172424Velofix™ SA Cervical CageNovember 22, 2017
K171749Velofix(tm) Interbody Fusion SystemJuly 13, 2017
K162189ANAX™ 5.5 Spinal SystemAugust 30, 2016
K143631Benefix Interspinous Fixation SystemSeptember 3, 2015
K150570ANAX OCT Spinal SystemJune 3, 2015
K143417ANAX 5.5 Spinal SystemFebruary 25, 2015
K132797L'DISQJuly 30, 2014