U I Medical Technologies Usa Inc

FDA Filings

This page includes the latest FDA filings for U I Medical Technologies Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3009554293
FEI Number3009554293
NameU&I Medical Technologies USA Inc.
Owner & OperatorU&i Corporation
Contact Address20, Sandan-ro 76beon-gil(Rd)
Uijeongbu-si KR-41 Gyeonggido 11781 KR
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address24835 La Palma Ave
Yorba Linda, CA 92887 US
Establishment TypeRepack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
U&I Medical Technologies USA Inc. [U&i Corporation]
Velofix? TLIF Cage2019-07-10
U&I Medical Technologies USA Inc. [U&i Corporation]
Velofix? Interbody Fusion System2019-02-06
U&I Medical Technologies USA Inc. [U&i Corporation]
Velofix? Interbody Fusion System2019-02-06
U&I Medical Technologies USA Inc. [U&i Corporation]
ANAX? OCT Spinal System2018-12-27
U&I Medical Technologies USA Inc. [U&i Corporation]
ANAX? OCT Spinal System2018-12-27
U&I Medical Technologies USA Inc. [U&i Corporation]
Velofix? TLIF Cage2018-12-17
U&I Medical Technologies USA Inc. [U&i Corporation]
ANAX? 5.5 CT SPINAL SYSTEM2018-12-17
U&I Medical Technologies USA Inc. [U&i Corporation]
Polarfix? Facet Screw System2018-01-09
U&I Medical Technologies USA Inc. [U&i Corporation]
ANAX? 5.5 SPINAL SYSTEM2017-12-13
U&I Medical Technologies USA Inc. [U&i Corporation]
Velofix? TLIF Cage2017-12-08
U&I Medical Technologies USA Inc. [U&i Corporation]
Velofix? SA Cervical Cage2017-12-07
U&I Medical Technologies USA Inc. [U&i Corporation]
Velofix Interbody Fusion System2017-07-17
U&I Medical Technologies USA Inc. [U&i Corporation]
ASPIRON ACP SYSTEM2016-09-12
U&I Medical Technologies USA Inc. [U&i Corporation]
Anax? MIS system2016-09-08
U&I Medical Technologies USA Inc. [U&i Corporation]
Anax? 5.5 MIS system2016-09-08
U&I Medical Technologies USA Inc. [U&i Corporation]
ANAX? 5.5 Spinal System2016-09-08
U&I Medical Technologies USA Inc. [U&i Corporation]
Anax? MIS system2016-09-08
U&I Medical Technologies USA Inc. [U&i Corporation]
Anax? 5.5 MIS system2016-09-08
U&I Medical Technologies USA Inc. [U&i Corporation]
ANAX? 5.5 Spinal System2016-09-08
U&I Medical Technologies USA Inc. [U&i Corporation]
ANAX OCT Spinal System2015-06-04
U&I Medical Technologies USA Inc. [U&i Corporation]
ANAX OCT Spinal System2015-06-04
U&I Medical Technologies USA Inc. [U&i Corporation]
ANAX 5.5 Spinal System2015-03-06
U&I Medical Technologies USA Inc. [U&i Corporation]
ANAX 5.5 Spinal System2015-03-06
U&I Medical Technologies USA Inc. [U&i Corporation]
Velofix Interbody Fusion System2014-07-31
U&I Medical Technologies USA Inc. [U&i Corporation]
Velofix Interbody Fusion System2014-07-31
U&I Medical Technologies USA Inc. [U&i Corporation]
L'DISQ2014-07-30
U&I Medical Technologies USA Inc. [U&i Corporation]
Catheter, General Purpose2014-06-02
U&I Medical Technologies USA Inc. [U&i Corporation]
Perfix Iliac Screw System2013-12-27
U&I Medical Technologies USA Inc. [U&i Corporation]
Perfix Iliac Screw System2013-12-27
U&I Medical Technologies USA Inc. [U&i Corporation]
Perfix Iliac Screw System2013-12-27
U&I Medical Technologies USA Inc. [U&i Corporation]
ANAX 5.5 Spinal System2013-12-27
U&I Medical Technologies USA Inc. [U&i Corporation]
ANAX 5.5 Spinal System2013-12-27
U&I Medical Technologies USA Inc. [U&i Corporation]
ASPIRON ACP System2013-12-27
U&I Medical Technologies USA Inc. [U&i Corporation]
Surgical Tray2013-01-23
U&I Medical Technologies USA Inc. [U&i Corporation]
Forceps2013-01-23
U&I Medical Technologies USA Inc. [U&i Corporation]
Dyna Locking Ankle Nail2012-07-19
U&I Medical Technologies USA Inc. [U&i Corporation]
Dyna Locking Cannulated Screw2012-01-19
U&I Medical Technologies USA Inc. [U&i Corporation]
Reamer2010-12-31
U&I Medical Technologies USA Inc. [U&i Corporation]
Slide hammer2010-12-31
U&I Medical Technologies USA Inc. [U&i Corporation]
Dyna Locking Trochanteric Nail2010-12-16
U&I Medical Technologies USA Inc. [U&i Corporation]
Dyna Locking Trochanteric Nail2010-12-16
U&I Medical Technologies USA Inc. [U&i Corporation]
Dyna Locking IM Nail2010-12-16
U&I Medical Technologies USA Inc. [U&i Corporation]
OptiGen Total Knee System2010-12-15
U&I Medical Technologies USA Inc. [U&i Corporation]
Perfix Spinal System2010-12-15
U&I Medical Technologies USA Inc. [U&i Corporation]
Perfix Spinal System2010-12-15
U&I Medical Technologies USA Inc. [U&i Corporation]
Maxima Anterior Cervical Plate System2008-12-23
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima ZS Spinal Fixation System2008-12-23
U&I Medical Technologies USA Inc. [U&i Corporation]
OPTIMA SPINAL SYSTEM2008-12-23
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima ZS Spinal Fixation System2008-12-23
U&I Medical Technologies USA Inc. [U&i Corporation]
OPTIMA SPINAL SYSTEM2008-12-23
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima ZS Spinal Fixation System2008-12-23
U&I Medical Technologies USA Inc. [U&i Corporation]
OPTIMA SPINAL SYSTEM2008-12-23
U&I Medical Technologies USA Inc. [U&i Corporation]
GLOBAL SPINAL FIXATION SYSTEM2008-12-23
U&I Medical Technologies USA Inc. [U&i Corporation]
GLOBAL SPINAL FIXATION SYSTEM2008-12-23
U&I Medical Technologies USA Inc. [U&i Corporation]
Rasp2008-12-23
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima ZS Spinal Hook System2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima Spinal Hook System2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima Spinal system2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima Spinal system2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima Spinal system2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima Spinal system2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima Spinal system2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima Spinal system2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima Spinal system2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima Spinal system2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
Optima Spinal system2007-12-21
U&I Medical Technologies USA Inc. [U&i Corporation]
MULTIPLE DRILL BITS2006-07-28
U&I Medical Technologies USA Inc. [U&i Corporation]
ADJUSTABLE DRILL BITS2006-07-28
U&I Medical Technologies USA Inc. [U&i Corporation]
MULTIPLE RETRACTORS2006-07-28
U&I Medical Technologies USA Inc. [U&i Corporation]
Finder(Lamina,Pedicle,Throat)2006-07-28
U&I Medical Technologies USA Inc. [U&i Corporation]
HOOK IMPACTOR2006-06-30
U&I Medical Technologies USA Inc. [U&i Corporation]
Bone Impactor2006-06-30
U&I Medical Technologies USA Inc. [U&i Corporation]
Torque Limiting T-Handle2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Temporary Fixation Pin2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
TESTER(STRAIGHT2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
SPREADER2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Retractor Fixation Pin2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
ROCKER2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
RATCHET HA2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
PERSUADER2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
LG)2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Handle(Ratchet-T,Ratchet Palm)2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Handle(Ratchet-T Cannulated)2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Handle(Persuader-T,FD Ratchet)2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Handle(Palm,I,T,Driving)2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
GUIDE PIN (SM2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Extender2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Distractor(Converging,Diverging)2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
CURVED)2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Adjustable Stopper2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Set Screw Driver2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Screw Driver2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Screw Driver& Holder2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Screw Adjustment Instrument2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Round Poly Screw Driver2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Poly Screw Driver Cannulated2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Poly Driver2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
POLY SCREW DRIVER2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Mono Screw Driver Extended2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Mini T Poly Screw Driver2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
MONO SCREW DRIVER2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Large Round Poly Screw Driver2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
LARGE POLY SCREW DRIVER2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Hex Driver 3.5mm Cannulated2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Guide Driver for HP Screw2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Dr. Ahn Poly Driver2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
4mm Driver with Adaptor2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
4.0mm Driver2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
4.0mm Driver with Adaptor 4 Hex2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
2.5MM HEX DRIVER2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Rod bender extended2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
ROD BENDER2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Plate Bender2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
IN-SITU ROD BENDER-RIGHT2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
IN-SITU ROD BENDER-LEFT2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
ROD PUSHER2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
ROD FORK2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Torque Wrench(GSFS,Transverse link)2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
TORQUE WRENCH FOR T LINK-COLLET TYP2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Derotation Wrench2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
DEROTATOR2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Axial Torque Wrench 4 Hex2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
AXIAL TORQUE WRENCH2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Sphere Handle Probe2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Sphere Handle Curved Probe2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Reaming Probe2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Probe Straight2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Probe Cannulated2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
PROBE2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Guide Probe2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
CURVED PROBE2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
TAP-8.0MM2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
TAP-7.5MM2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
TAP-7.0MM2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
TAP-6.OMM2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
TAP-5.OMM2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
TAP-4.OMM2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Sharp Tap2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Cannulated Tap2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Adjustable Tap2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
ROD TEMPLATE 400MM2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
ROD TEMPLATE 200MM2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
COMPRESSOR2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Awl Extended2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Awl Cannulated2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
AWL2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Screw gauge2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Temporary Fixation Pin Driver2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Set Screw Inserting Guide2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Set Screw Guide Extended2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
SET SCREW DRIVER GUIDE2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
ROD HOLDER2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Poly Head Adjuster2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Holder(Plate,Hook,Rod,Housing,T-Lin2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
HOUSING HOLDER2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Guide Driver2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
GUIDE PIN DRIVER2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Drill Guide2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Alignment Guide2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
ANTI TORQU2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Surgical Cutter2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Reduction Cutter2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
REDUCTION HOUSING CUTTER2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Various Types of Trayes2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Various Types of Covers2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Various Types of Containers2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
Various Types of Cases2005-01-18
U&I Medical Technologies USA Inc. [U&i Corporation]
SURGICAL INSTRUMENT TRAY2005-01-18

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