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

U&I Corporation

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

U&I Corporation — FDA 510(k) Submissions

U&I Corporation has submitted 23 FDA 510(k) premarket notifications since 2013, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Appliance, Fixation, Spinal Intervertebral Body, Orthosis, Spondylolisthesis Spinal Fixation, Intervertebral Fusion Device With Bone Graft, Lumbar, Thoracolumbosacral Pedicle Screw System, Posterior Cervical Screw System . Use the specialty filter in the sidebar to narrow results.

23 devices
1–23 of 23
Aspiron S ACP System
K220147 · KWQ Appliance, Fixation,... · Orthopedic
Feb 2022 28d
Velofix SA Cervical Cage
K210573 · OVE Intervertebral Fusion... · Orthopedic
Nov 2021 266d
Velofix TLIF Cage
K183243 · MAX Intervertebral Fusion... · Orthopedic
Jul 2019 231d
Velofix Interbody Fusion System
K190067 · ODP Intervertebral Fusion... · Orthopedic
Feb 2019 20d
SECULOK? ACP System
K190053 · KWQ Appliance, Fixation,... · Orthopedic
Feb 2019 21d
CBT Screw Fixation System
K181824 · NKB Thoracolumbosacral... · Orthopedic
Dec 2018 157d
ANAX? OCT Spinal System
K183383 · NKG Posterior Cervical Screw... · Orthopedic
Dec 2018 6d
Velofix TLIF Cage
K181829 · MAX Intervertebral Fusion... · Orthopedic
Nov 2018 128d
SECULOK? ACP System
K182055 · KWQ Appliance, Fixation,... · Orthopedic
Sep 2018 41d
SECULOK? Suture Anchor
K180759 · MBI Fastener, Fixation,... · Orthopedic
Aug 2018 140d
Facet Screw Fixation System
K173198 · MRW System, Facet Screw... · Orthopedic
Jan 2018 93d
ANAX 5.5? Spinal System
K173524 · NKB Thoracolumbosacral... · Orthopedic
Dec 2017 29d
Velofix? TLIF Cage
K172419 · MAX Intervertebral Fusion... · Orthopedic
Dec 2017 116d
Velofix? SA Cervical Cage
K172424 · OVE Intervertebral Fusion... · Orthopedic
Nov 2017 104d
Velofix(tm) Interbody Fusion System
K171749 · ODP Intervertebral Fusion... · Orthopedic
Jul 2017 30d
ANAX? 5.5 Spinal System
K162189 · MNH Orthosis,... · Orthopedic
Aug 2016 26d
Benefix Interspinous Fixation System
K143631 · PEK Spinous Process Plate · Orthopedic
Sep 2015 255d
ANAX OCT Spinal System
K150570 · NKG Posterior Cervical Screw... · Orthopedic
Jun 2015 89d
ANAX 5.5 Spinal System
K143417 · MNH Orthosis,... · Orthopedic
Feb 2015 89d
L'DISQ
K132797 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jul 2014 327d
PERFIX ILIAC SCREW SYSTEM
K132218 · MNH Orthosis,... · Orthopedic
Dec 2013 153d
ANAX 5.5 SPINAL SYSTEM
K132101 · MNH Orthosis,... · Orthopedic
Nov 2013 140d
ASPIRON ACP SYSTEM
K131200 · KWQ Appliance, Fixation,... · Orthopedic
Aug 2013 122d
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