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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