U&I Corporation - FDA 510(k) Cleared Devices
23
Total
23
Cleared
0
Denied
FDA 510(k) cleared devices by U&I Corporation Orthopedic ✕
22 devices
Cleared
Feb 16, 2022
Aspiron S ACP System
Orthopedic
28d
Cleared
Nov 19, 2021
Velofix SA Cervical Cage
Orthopedic
266d
Cleared
Jul 10, 2019
Velofix TLIF Cage
Orthopedic
231d
Cleared
Feb 04, 2019
Velofix Interbody Fusion System
Orthopedic
20d
Cleared
Feb 01, 2019
SECULOK™ ACP System
Orthopedic
21d
Cleared
Dec 13, 2018
CBT Screw Fixation System
Orthopedic
157d
Cleared
Dec 12, 2018
ANAX™ OCT Spinal System
Orthopedic
6d
Cleared
Nov 14, 2018
Velofix TLIF Cage
Orthopedic
128d
Cleared
Sep 10, 2018
SECULOK™ ACP System
Orthopedic
41d
Cleared
Aug 09, 2018
SECULOK™ Suture Anchor
Orthopedic
140d
Cleared
Jan 03, 2018
Facet Screw Fixation System
Orthopedic
93d
Cleared
Dec 13, 2017
ANAX 5.5™ Spinal System
Orthopedic
29d
Cleared
Dec 04, 2017
Velofix™ TLIF Cage
Orthopedic
116d
Cleared
Nov 22, 2017
Velofix™ SA Cervical Cage
Orthopedic
104d
Cleared
Jul 13, 2017
Velofix(tm) Interbody Fusion System
Orthopedic
30d
Cleared
Aug 30, 2016
ANAX™ 5.5 Spinal System
Orthopedic
26d
Cleared
Sep 03, 2015
Benefix Interspinous Fixation System
Orthopedic
255d
Cleared
Jun 03, 2015
ANAX OCT Spinal System
Orthopedic
89d
Cleared
Feb 25, 2015
ANAX 5.5 Spinal System
Orthopedic
89d
Cleared
Dec 17, 2013
PERFIX ILIAC SCREW SYSTEM
Orthopedic
153d
Cleared
Nov 25, 2013
ANAX 5.5 SPINAL SYSTEM
Orthopedic
140d
Cleared
Aug 29, 2013
ASPIRON ACP SYSTEM
Orthopedic
122d