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

Total

Cleared

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.

U&I Corporation is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.

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

23 devices

1-12 of 23

Velofix SA Cervical Cage

Velofix Interbody Fusion System

CBT Screw Fixation System

K181824 · NKB

Orthopedic · 157d

Cleared Dec 12, 2018

ANAX™ OCT Spinal System

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

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

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

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