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FDA 510(k) Applications Submitted by U&I Corporation
FDA 510(k) Number
Submission Date
Device Name
Applicant
K171749
06/13/2017
Velofix(tm) Interbody Fusion System
U&i Corporation
K173524
11/14/2017
ANAX 5.5Ö Spinal System
U&I Corporation
K183243
11/21/2018
Velofix TLIF Cage
U&i Corporation
K190067
01/15/2019
Velofix Interbody Fusion System
U&i Corporation
K210573
02/26/2021
Velofix SA Cervical Cage
U&I Corporation
K181824
07/09/2018
CBT Screw Fixation System
U&i Corporation
K181829
07/09/2018
Velofix TLIF Cage
U&I Corporation
K172419
08/10/2017
VelofixÖ TLIF Cage
U&i Corporation
K172424
08/10/2017
VelofixÖ SA Cervical Cage
U&I Corporation
K162189
08/04/2016
ANAXÖ 5.5 Spinal System
U&I Corporation
K190053
01/11/2019
SECULOKÖ ACP System
U&i Corporation
K182055
07/31/2018
SECULOKÖ ACP System
U&i Corporation
K220147
01/19/2022
Aspiron S ACP System
U&I Corporation
K173198
10/02/2017
Facet Screw Fixation System
U&i Corporation
K150570
03/06/2015
ANAX OCT Spinal System
U&I Corporation
K143417
11/28/2014
ANAX 5.5 Spinal System
U&I Corporation
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