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

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

23 submissions · 23 cleared · Since 2013

Recent clearances: Aspiron S ACP System, Velofix SA Cervical Cage, Velofix TLIF Cage

23

Total

23

Cleared

0

Denied

FDA 510(k) Regulatory Record - U&I Corporation Orthopedic ✕

22 devices

1-12 of 22

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