Medical Device Manufacturer · KR , Uijeongbu-Si, Gyeonggi-Do

U&I Corporation - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 2013
23
Total
23
Cleared
0
Denied

U&I Corporation has 23 FDA 510(k) cleared orthopedic devices. Based in Uijeongbu-Si, Gyeonggi-Do, KR.

Last cleared in 2022. Active since 2013.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - U&I Corporation
23 devices
1-23 of 23
Cleared Feb 16, 2022
Aspiron S ACP System
K220147 · KWQ
Orthopedic · 28d
Cleared Nov 19, 2021
Velofix SA Cervical Cage
K210573 · OVE
Orthopedic · 266d
Cleared Jul 10, 2019
Velofix TLIF Cage
K183243 · MAX
Orthopedic · 231d
Cleared Feb 04, 2019
Velofix Interbody Fusion System
K190067 · ODP
Orthopedic · 20d
Cleared Feb 01, 2019
SECULOK™ ACP System
K190053 · KWQ
Orthopedic · 21d
Cleared Dec 13, 2018
CBT Screw Fixation System
K181824 · NKB
Orthopedic · 157d
Cleared Dec 12, 2018
ANAX™ OCT Spinal System
K183383 · NKG
Orthopedic · 6d
Cleared Nov 14, 2018
Velofix TLIF Cage
K181829 · MAX
Orthopedic · 128d
Cleared Sep 10, 2018
SECULOK™ ACP System
K182055 · KWQ
Orthopedic · 41d
Cleared Aug 09, 2018
SECULOK™ Suture Anchor
K180759 · MBI
Orthopedic · 140d
Cleared Jan 03, 2018
Facet Screw Fixation System
K173198 · MRW
Orthopedic · 93d
Cleared Dec 13, 2017
ANAX 5.5™ Spinal System
K173524 · NKB
Orthopedic · 29d
Cleared Dec 04, 2017
Velofix™ TLIF Cage
K172419 · MAX
Orthopedic · 116d
Cleared Nov 22, 2017
Velofix™ SA Cervical Cage
K172424 · OVE
Orthopedic · 104d
Cleared Jul 13, 2017
Velofix(tm) Interbody Fusion System
K171749 · ODP
Orthopedic · 30d
Cleared Aug 30, 2016
ANAX™ 5.5 Spinal System
K162189 · MNH
Orthopedic · 26d
Cleared Sep 03, 2015
Benefix Interspinous Fixation System
K143631 · PEK
Orthopedic · 255d
Cleared Jun 03, 2015
ANAX OCT Spinal System
K150570 · NKG
Orthopedic · 89d
Cleared Feb 25, 2015
ANAX 5.5 Spinal System
K143417 · MNH
Orthopedic · 89d
Cleared Jul 30, 2014
L'DISQ
K132797 · GEI
General & Plastic Surgery · 327d
Cleared Dec 17, 2013
PERFIX ILIAC SCREW SYSTEM
K132218 · MNH
Orthopedic · 153d
Cleared Nov 25, 2013
ANAX 5.5 SPINAL SYSTEM
K132101 · MNH
Orthopedic · 140d
Cleared Aug 29, 2013
ASPIRON ACP SYSTEM
K131200 · KWQ
Orthopedic · 122d
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