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

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