Rachel Kennedy

FDA Filings

This page includes the latest FDA filings for Rachel Kennedy. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004859018
FEI Number3004859018
NameRachel Kennedy
Owner & OperatorBeijing Wandong Medical Technology Co.,Ltd.
Contact AddressBuilding 3, No .9, Jiuxianqiaodong Road Chaoyang District
Beijing CN-11 Beijing 100015 CN
Official Correspondent
  • Wang Huan
  • 86-10-65794660-x
US Agent
Importing Logistics Registration
ImporterCHINA RESOURCES WANDONG MEDICAL EQUIPMENT CO.
Addressjiuxiaoqiao
Beijing, 100015 CHINA
Importer TypeAgent
SubdivisionCN-11
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5353 Wayzata Boulevard, Suite 505
MINNEAPOLIS, MN 55416 US
Establishment TypeManufacture Medical Device

Registration Number3006130229
FEI Number3006130229
NameRachel Kennedy
Owner & OperatorFIN-CERAMICA FAENZA SPA
Contact Addressvia ravegnana186
faenza IT-RA Ravenna 48018 IT
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5353 Wayzata Blvd, Suite 505
Minneapolis, MN 55416 US
Establishment TypeManufacture Medical Device

Registration Number9617297
FEI Number3003200961
NameRachel Kennedy
Owner & OperatorU&i Corporation
Contact Address20, Sandan-ro 76beon-gil(Rd)
Uijeongbu-si KR-41 Gyeonggido 11781 KR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5353 Wayzata Blvd Ste 505
MINNEAPOLIS, MN 55416 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
Rachel Kennedy [U&i Corporation]
Velofix? TLIF Cage2019-07-10
Rachel Kennedy [U&i Corporation]
ASPIRON? S ACP System2019-03-20
Rachel Kennedy [U&i Corporation]
Velofix? Interbody Fusion System2019-02-06
Rachel Kennedy [U&i Corporation]
Velofix? Interbody Fusion System2019-02-06
Rachel Kennedy [U&i Corporation]
ANAX? OCT Spinal System2018-12-27
Rachel Kennedy [U&i Corporation]
ANAX? OCT Spinal System2018-12-27
Rachel Kennedy [U&i Corporation]
Velofix? TLIF Cage2018-12-17
Rachel Kennedy [U&i Corporation]
ANAX? 5.5 CT SPINAL SYSTEM2018-12-17
Rachel Kennedy [U&i Corporation]
SECULOK? Suture Anchor2018-08-09
Rachel Kennedy [U&i Corporation]
Polarfix? Facet Screw System2018-01-09
Rachel Kennedy [U&i Corporation]
ANAX? 5.5 SPINAL SYSTEM2017-12-13
Rachel Kennedy [U&i Corporation]
Velofix? TLIF Cage2017-12-08
Rachel Kennedy [U&i Corporation]
Velofix? SA Cervical Cage2017-12-07
Rachel Kennedy [U&i Corporation]
Velofix Interbody Fusion System2017-07-17
Rachel Kennedy [U&i Corporation]
ASPIRON ACP SYSTEM2016-09-12
Rachel Kennedy [U&i Corporation]
Anax? MIS system2016-09-08
Rachel Kennedy [U&i Corporation]
Anax? 5.5 MIS system2016-09-08
Rachel Kennedy [U&i Corporation]
ANAX? 5.5 Spinal System2016-09-08
Rachel Kennedy [U&i Corporation]
Anax? MIS system2016-09-08
Rachel Kennedy [U&i Corporation]
Anax? 5.5 MIS system2016-09-08
Rachel Kennedy [U&i Corporation]
ANAX? 5.5 Spinal System2016-09-08
Rachel Kennedy [U&i Corporation]
ANAX OCT Spinal System2015-06-04
Rachel Kennedy [U&i Corporation]
ANAX OCT Spinal System2015-06-04
Rachel Kennedy [U&i Corporation]
ANAX 5.5 Spinal System2015-03-06
Rachel Kennedy [U&i Corporation]
ANAX 5.5 Spinal System2015-03-06
Rachel Kennedy [U&i Corporation]
Velofix Interbody Fusion System2014-07-31
Rachel Kennedy [U&i Corporation]
Velofix Interbody Fusion System2014-07-31
Rachel Kennedy [U&i Corporation]
L'DISQ2014-07-30
Rachel Kennedy [U&i Corporation]
Catheter, General Purpose2014-06-02
Rachel Kennedy [U&i Corporation]
Perfix Iliac Screw System2013-12-27
Rachel Kennedy [U&i Corporation]
Perfix Iliac Screw System2013-12-27
Rachel Kennedy [U&i Corporation]
Perfix Iliac Screw System2013-12-27
Rachel Kennedy [U&i Corporation]
ANAX 5.5 Spinal System2013-12-27
Rachel Kennedy [U&i Corporation]
ANAX 5.5 Spinal System2013-12-27
Rachel Kennedy [U&i Corporation]
ASPIRON ACP System2013-12-27
Rachel Kennedy [U&i Corporation]
SpineTune TL 8.0 and 8.5 mm2013-01-23
Rachel Kennedy [U&i Corporation]
SpineTune TL 8.0 and 8.5 mm2013-01-23
Rachel Kennedy [U&i Corporation]
SpineTune TL 8.0 and 8.5 mm2013-01-23
Rachel Kennedy [U&i Corporation]
SpineTune TL Cannulated2013-01-23
Rachel Kennedy [U&i Corporation]
SpineTune TL Cannulated2013-01-23
Rachel Kennedy [U&i Corporation]
SpineTune TL Cannulated2013-01-23
Rachel Kennedy [U&i Corporation]
C-Plate2013-01-23
Rachel Kennedy [U&i Corporation]
SpineTune TL2013-01-23
Rachel Kennedy [U&i Corporation]
SpineTune TL2013-01-23
Rachel Kennedy [U&i Corporation]
SpineTune TL2013-01-23
Rachel Kennedy [U&i Corporation]
Surgical Tray2013-01-23
Rachel Kennedy [U&i Corporation]
Forceps2013-01-23
Rachel Kennedy [U&i Corporation]
Dyna Locking Ankle Nail2012-07-19
Rachel Kennedy [U&i Corporation]
Dyna Locking Cannulated Screw2012-01-19
Rachel Kennedy [U&i Corporation]
Reamer2010-12-31
Rachel Kennedy [U&i Corporation]
Slide hammer2010-12-31
Rachel Kennedy [U&i Corporation]
Dyna Locking Trochanteric Nail2010-12-16
Rachel Kennedy [U&i Corporation]
Dyna Locking Trochanteric Nail2010-12-16
Rachel Kennedy [U&i Corporation]
Dyna Locking IM Nail2010-12-16
Rachel Kennedy [U&i Corporation]
OptiGen Total Knee System2010-12-15
Rachel Kennedy [U&i Corporation]
Perfix Spinal System2010-12-15
Rachel Kennedy [U&i Corporation]
Perfix Spinal System2010-12-15
Rachel Kennedy [Beijing Wandong Medical Technology Co.,Ltd.]
BEIJING WANDONG MEDICAL TECHNOLOGY CO.,LTD2009-04-13
Rachel Kennedy [Beijing Wandong Medical Technology Co.,Ltd.]
BEIJING WANDONG MEDICAL TECHNOLOGY CO.,LTD2009-04-13
Rachel Kennedy [U&i Corporation]
Maxima Anterior Cervical Plate System2008-12-23
Rachel Kennedy [U&i Corporation]
Optima ZS Spinal Fixation System2008-12-23
Rachel Kennedy [U&i Corporation]
OPTIMA SPINAL SYSTEM2008-12-23
Rachel Kennedy [U&i Corporation]
Optima ZS Spinal Fixation System2008-12-23
Rachel Kennedy [U&i Corporation]
OPTIMA SPINAL SYSTEM2008-12-23
Rachel Kennedy [U&i Corporation]
Optima ZS Spinal Fixation System2008-12-23
Rachel Kennedy [U&i Corporation]
OPTIMA SPINAL SYSTEM2008-12-23
Rachel Kennedy [U&i Corporation]
GLOBAL SPINAL FIXATION SYSTEM2008-12-23
Rachel Kennedy [U&i Corporation]
GLOBAL SPINAL FIXATION SYSTEM2008-12-23
Rachel Kennedy [U&i Corporation]
Rasp2008-12-23
Rachel Kennedy [U&i Corporation]
Optima ZS Spinal Hook System2007-12-21
Rachel Kennedy [U&i Corporation]
Optima Spinal Hook System2007-12-21
Rachel Kennedy [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
Rachel Kennedy [U&i Corporation]
Optima Spinal system2007-12-21
Rachel Kennedy [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
Rachel Kennedy [U&i Corporation]
Optima Spinal system2007-12-21
Rachel Kennedy [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
Rachel Kennedy [U&i Corporation]
Optima Spinal system2007-12-21
Rachel Kennedy [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
Rachel Kennedy [U&i Corporation]
Optima Spinal system2007-12-21
Rachel Kennedy [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
Rachel Kennedy [U&i Corporation]
Optima Spinal system2007-12-21
Rachel Kennedy [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
Rachel Kennedy [U&i Corporation]
Optima Spinal system2007-12-21
Rachel Kennedy [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
Rachel Kennedy [U&i Corporation]
Optima Spinal system2007-12-21
Rachel Kennedy [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
Rachel Kennedy [U&i Corporation]
Optima Spinal system2007-12-21
Rachel Kennedy [U&i Corporation]
Optima ZS Spinal Fixation System2007-12-21
Rachel Kennedy [U&i Corporation]
Optima Spinal system2007-12-21
Rachel Kennedy [Beijing Wandong Medical Technology Co.,Ltd.]
BEIJING WANDONG MEDICAL TECHNOLOGY CO.,LTD2007-11-12
Rachel Kennedy [U&i Corporation]
MULTIPLE DRILL BITS2006-07-28
Rachel Kennedy [U&i Corporation]
ADJUSTABLE DRILL BITS2006-07-28
Rachel Kennedy [U&i Corporation]
MULTIPLE RETRACTORS2006-07-28
Rachel Kennedy [U&i Corporation]
Finder(Lamina,Pedicle,Throat)2006-07-28
Rachel Kennedy [U&i Corporation]
HOOK IMPACTOR2006-06-30
Rachel Kennedy [U&i Corporation]
Bone Impactor2006-06-30
Rachel Kennedy [U&i Corporation]
Torque Limiting T-Handle2005-01-18
Rachel Kennedy [U&i Corporation]
Temporary Fixation Pin2005-01-18
Rachel Kennedy [U&i Corporation]
TESTER(STRAIGHT2005-01-18
Rachel Kennedy [U&i Corporation]
SPREADER2005-01-18
Rachel Kennedy [U&i Corporation]
Retractor Fixation Pin2005-01-18
Rachel Kennedy [U&i Corporation]
ROCKER2005-01-18
Rachel Kennedy [U&i Corporation]
RATCHET HA2005-01-18
Rachel Kennedy [U&i Corporation]
PERSUADER2005-01-18
Rachel Kennedy [U&i Corporation]
LG)2005-01-18
Rachel Kennedy [U&i Corporation]
Handle(Ratchet-T,Ratchet Palm)2005-01-18
Rachel Kennedy [U&i Corporation]
Handle(Ratchet-T Cannulated)2005-01-18
Rachel Kennedy [U&i Corporation]
Handle(Persuader-T,FD Ratchet)2005-01-18
Rachel Kennedy [U&i Corporation]
Handle(Palm,I,T,Driving)2005-01-18
Rachel Kennedy [U&i Corporation]
GUIDE PIN (SM2005-01-18
Rachel Kennedy [U&i Corporation]
Extender2005-01-18
Rachel Kennedy [U&i Corporation]
Distractor(Converging,Diverging)2005-01-18
Rachel Kennedy [U&i Corporation]
CURVED)2005-01-18
Rachel Kennedy [U&i Corporation]
Adjustable Stopper2005-01-18
Rachel Kennedy [U&i Corporation]
Set Screw Driver2005-01-18
Rachel Kennedy [U&i Corporation]
Screw Driver2005-01-18
Rachel Kennedy [U&i Corporation]
Screw Driver& Holder2005-01-18
Rachel Kennedy [U&i Corporation]
Screw Adjustment Instrument2005-01-18
Rachel Kennedy [U&i Corporation]
Round Poly Screw Driver2005-01-18
Rachel Kennedy [U&i Corporation]
Poly Screw Driver Cannulated2005-01-18
Rachel Kennedy [U&i Corporation]
Poly Driver2005-01-18
Rachel Kennedy [U&i Corporation]
POLY SCREW DRIVER2005-01-18
Rachel Kennedy [U&i Corporation]
Mono Screw Driver Extended2005-01-18
Rachel Kennedy [U&i Corporation]
Mini T Poly Screw Driver2005-01-18
Rachel Kennedy [U&i Corporation]
MONO SCREW DRIVER2005-01-18
Rachel Kennedy [U&i Corporation]
Large Round Poly Screw Driver2005-01-18
Rachel Kennedy [U&i Corporation]
LARGE POLY SCREW DRIVER2005-01-18
Rachel Kennedy [U&i Corporation]
Hex Driver 3.5mm Cannulated2005-01-18
Rachel Kennedy [U&i Corporation]
Guide Driver for HP Screw2005-01-18
Rachel Kennedy [U&i Corporation]
Dr. Ahn Poly Driver2005-01-18
Rachel Kennedy [U&i Corporation]
4mm Driver with Adaptor2005-01-18
Rachel Kennedy [U&i Corporation]
4.0mm Driver2005-01-18
Rachel Kennedy [U&i Corporation]
4.0mm Driver with Adaptor 4 Hex2005-01-18
Rachel Kennedy [U&i Corporation]
2.5MM HEX DRIVER2005-01-18
Rachel Kennedy [U&i Corporation]
Rod bender extended2005-01-18
Rachel Kennedy [U&i Corporation]
ROD BENDER2005-01-18
Rachel Kennedy [U&i Corporation]
Plate Bender2005-01-18
Rachel Kennedy [U&i Corporation]
IN-SITU ROD BENDER-RIGHT2005-01-18
Rachel Kennedy [U&i Corporation]
IN-SITU ROD BENDER-LEFT2005-01-18
Rachel Kennedy [U&i Corporation]
ROD PUSHER2005-01-18
Rachel Kennedy [U&i Corporation]
ROD FORK2005-01-18
Rachel Kennedy [U&i Corporation]
Torque Wrench(GSFS,Transverse link)2005-01-18
Rachel Kennedy [U&i Corporation]
TORQUE WRENCH FOR T LINK-COLLET TYP2005-01-18
Rachel Kennedy [U&i Corporation]
Derotation Wrench2005-01-18
Rachel Kennedy [U&i Corporation]
DEROTATOR2005-01-18
Rachel Kennedy [U&i Corporation]
Axial Torque Wrench 4 Hex2005-01-18
Rachel Kennedy [U&i Corporation]
AXIAL TORQUE WRENCH2005-01-18
Rachel Kennedy [U&i Corporation]
Sphere Handle Probe2005-01-18
Rachel Kennedy [U&i Corporation]
Sphere Handle Curved Probe2005-01-18
Rachel Kennedy [U&i Corporation]
Reaming Probe2005-01-18
Rachel Kennedy [U&i Corporation]
Probe Straight2005-01-18
Rachel Kennedy [U&i Corporation]
Probe Cannulated2005-01-18
Rachel Kennedy [U&i Corporation]
PROBE2005-01-18
Rachel Kennedy [U&i Corporation]
Guide Probe2005-01-18
Rachel Kennedy [U&i Corporation]
CURVED PROBE2005-01-18
Rachel Kennedy [U&i Corporation]
TAP-8.0MM2005-01-18
Rachel Kennedy [U&i Corporation]
TAP-7.5MM2005-01-18
Rachel Kennedy [U&i Corporation]
TAP-7.0MM2005-01-18
Rachel Kennedy [U&i Corporation]
TAP-6.OMM2005-01-18
Rachel Kennedy [U&i Corporation]
TAP-5.OMM2005-01-18
Rachel Kennedy [U&i Corporation]
TAP-4.OMM2005-01-18
Rachel Kennedy [U&i Corporation]
Sharp Tap2005-01-18
Rachel Kennedy [U&i Corporation]
Cannulated Tap2005-01-18
Rachel Kennedy [U&i Corporation]
Adjustable Tap2005-01-18
Rachel Kennedy [U&i Corporation]
ROD TEMPLATE 400MM2005-01-18
Rachel Kennedy [U&i Corporation]
ROD TEMPLATE 200MM2005-01-18
Rachel Kennedy [U&i Corporation]
COMPRESSOR2005-01-18
Rachel Kennedy [U&i Corporation]
Awl Extended2005-01-18
Rachel Kennedy [U&i Corporation]
Awl Cannulated2005-01-18
Rachel Kennedy [U&i Corporation]
AWL2005-01-18
Rachel Kennedy [U&i Corporation]
Screw gauge2005-01-18
Rachel Kennedy [U&i Corporation]
Temporary Fixation Pin Driver2005-01-18
Rachel Kennedy [U&i Corporation]
Set Screw Inserting Guide2005-01-18
Rachel Kennedy [U&i Corporation]
Set Screw Guide Extended2005-01-18
Rachel Kennedy [U&i Corporation]
SET SCREW DRIVER GUIDE2005-01-18
Rachel Kennedy [U&i Corporation]
ROD HOLDER2005-01-18
Rachel Kennedy [U&i Corporation]
Poly Head Adjuster2005-01-18
Rachel Kennedy [U&i Corporation]
Holder(Plate,Hook,Rod,Housing,T-Lin2005-01-18
Rachel Kennedy [U&i Corporation]
HOUSING HOLDER2005-01-18
Rachel Kennedy [U&i Corporation]
Guide Driver2005-01-18
Rachel Kennedy [U&i Corporation]
GUIDE PIN DRIVER2005-01-18
Rachel Kennedy [U&i Corporation]
Drill Guide2005-01-18
Rachel Kennedy [U&i Corporation]
Alignment Guide2005-01-18
Rachel Kennedy [U&i Corporation]
ANTI TORQU2005-01-18
Rachel Kennedy [U&i Corporation]
Surgical Cutter2005-01-18
Rachel Kennedy [U&i Corporation]
Reduction Cutter2005-01-18
Rachel Kennedy [U&i Corporation]
REDUCTION HOUSING CUTTER2005-01-18
Rachel Kennedy [U&i Corporation]
Various Types of Trayes2005-01-18
Rachel Kennedy [U&i Corporation]
Various Types of Covers2005-01-18
Rachel Kennedy [U&i Corporation]
Various Types of Containers2005-01-18
Rachel Kennedy [U&i Corporation]
Various Types of Cases2005-01-18
Rachel Kennedy [U&i Corporation]
SURGICAL INSTRUMENT TRAY2005-01-18

Similar & Related FDA Registered Companies

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2018101864279Xiamen,China (Mainland) -> Los Angeles, CaliforniaPOLYESTER FOLDABLE BAG .28 CTN
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