Medtronic (Changzhou) Medical Devices Technology Co., Ltd

FDA Device Registration & Listing · Changzhou Jiangsu, CN · Registration 3005677016

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005677016
FEI Number
3005677016
Entity Name
Medtronic (Changzhou) Medical Devices Technology Co., Ltd
City/State/Country
Changzhou Jiangsu, CN
Establishment Address
Building #3, 11 ChangJiang North Road, Xinbei District, Changzhou Jiangsu 213022, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Medtronic, Inc. (Owner Number: 2112641)
Owner / Operator Contact Address
710 Medtronic Parkway, Minneapolis, MN 55432, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Sovereign Spinal System MULTIPLE (DRIVER-EXTRACTORS) IB3D™ PL Spinal System Verte-Stack Crescent VERTEX® Reconstruction System CD HORIZON® Spinal System Medtronic Reusable Instrument IB3D™ PL Spinal System CD Horizon Spinal System SOVEREIGN™ SPINAL SYSTEM CD HORIZON® Spinal System Manual surgical instrument for general use CD HORIZON Longitude 2 Instruments and Rods CD HORIZON® Spinal System VERTEX® Reconstruction System Curette CD HORIZON® Fenestrated Screw Set KYPHON Cement Delivery System KyphX Bone Filler Device Medtronic Reusable Instrument Rasp DIVERGENCE Anterior Cervical Fusion System CD HORIZON® Spinal System CD Horizon™ Modular 5.5/6mm Spinal System Capstone Spinal System MULTIPLE TWIST Drill; Introducer Tool MICRO-FRANCE BIT DRILLS DRILL BIT (ORTHOPEDIC MA INFINITY™ Occipitocervical Upper Thoracic System ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology PROBE (ORTHOPEDIC MANU CD Horizon™ ModuLeX™ Spinal System Tray, Surgical, Instrument instrument tray Aspen Bard-Parker Wire Nest RETRACTOR RadiaLux™ Spacekeeper Anteralign Spinal System with Titan nanolOCk DIVERGENCE Anterior Cervical Fusion System T2 STRATOSPHERE™ Expandable Corpectomy System CD Perc Trauma CD Horizon™ ModuLeX™ Spinal System MICRO-FRANCE SCREWDRIVER Medtronic Reusable Instrument Anteralign™ Spinal system with Titan nanoLOCK™ Surface Technology WRENCH CLYDESDALE Spinal System CD HORIZON Spinal System NETTERVILLE LARYNGOLOPLASTIC STAGE TOWEL GRIP CLIP - CLIP MULTIPLE (ORTHOPEDIC CLAMPS) SOVEREIGN Spinal System VERTEX® Reconstruction System CD HORIZON® Spinal System Crescent Spinal System Interbody F Catalyft™ PL Expandable Interbody System CAPSTONE-L SPINAL SYSTEM CD HorizonSpinal System CD Horizon™ ModuLeX™ Spinal System Anteralign™ Spinal System with Titan NanoLOCK™ Surface Technology Navigated Instruments ARTHROSCOPE INFINITY™ Occipitocervical Upper Thoracic System General Instrument PASS LP Spinal System CAPSTONE Spinal System METRx Microscope CD HORIZON® Spinal System Verte-Stack Capstone L T2 STRATSOPHERE™ Expandable Corpectomy System EM ENT Navigated Suction DIVERGENCE-L" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM Medtronic Reusable Instrument Pyramid +4 Anterior Lumbar Plate CD HORIZON® Spinal System VERTEX® Reconstruction System dilator, lachrymal Chisel, Surgical, Manual , MOTORS DRILLS SURGICAL DRIVE SYSTEM CD Horizon Spinal System Anteralign™ Spinal system with Titan nanoLOCK™ Surface Technology General Instruments

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-02-02
HWB Extractor Orthopedic Class 1 888.4540 2005-05-31
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
HWA Impactor Orthopedic Class 1 888.4540 2002-11-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2011-01-06
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2011-01-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2011-01-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2011-01-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2011-01-06
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2011-01-06
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-11-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-09-22
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2017-09-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-09-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-09-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-09-22
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 1994-11-09
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-10-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-10-22
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2012-10-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-10-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-10-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-10-22
HTF Curette General, Plastic Surgery Class 1 878.4800 2005-05-31
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2008-02-27
KTZ Caliper Orthopedic Class 1 888.4150 2010-02-22
HTR Rasp General, Plastic Surgery Class 1 878.4800 2005-05-31
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2015-02-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-10-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2020-10-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-10-12
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2020-10-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2020-10-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2011-08-10
HTW Bit, Drill Orthopedic Class 1 888.4540 2006-06-29
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-02-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-02-03
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-02-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-10-09
HXB Probe Orthopedic Class 1 888.4540 2006-06-29
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2001-03-30
GAD Retractor General, Plastic Surgery Class 1 878.4800 2005-03-23
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-12-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-12-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-12-15
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-10-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-10-10
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-03-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2008-01-31
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2008-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-01-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-06-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-06-07
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-06-07
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2022-06-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-06-07
HXZ Cutter, Wire Orthopedic Class 1 888.4540 1992-12-12
HXX Screwdriver Orthopedic Class 1 888.4540 1992-12-12
HXW Bender Orthopedic Class 1 888.4540 1992-12-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-04-13
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-04-13
HXC Wrench Orthopedic Class 1 888.4540 1992-12-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2009-02-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-04-01
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-04-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-04-01
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2015-04-01
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2015-04-01
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-04-01
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-04-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-04-01
HXD Clamp General, Plastic Surgery Class 1 878.4800 2005-05-31
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2009-11-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2010-05-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-06-03
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-07-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-05-06
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-05-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-05-06
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2014-05-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-05-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-05-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-06-19
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2023-06-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-06-19
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-06-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-06-19
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-08-01
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2005-03-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-02-19
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-02-19
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2006-06-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2008-05-08
HRX Arthroscope Orthopedic Class 2 888.1100 2008-02-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-04-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2018-04-04
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-04-04
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2018-04-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-04-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2018-04-04
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-09-06
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2016-04-28
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2015-06-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-06-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-06-23
HWJ Awl Orthopedic Class 1 888.4540 2002-11-19
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2010-03-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-02-01
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 1992-07-20
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 1994-11-09
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2006-10-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-01-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-31
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-10-26
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2021-09-09

Official Correspondent

No official correspondent registered.

US Agent Details

Alison Webster Email: alison.s.webster@medtronic.com Phone: (901) 3992384

Related Public Records

Same Entity

Medtronic, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007042319 HeartWare, Inc. Miami Lakes, FL, US
3004497303 MEDTRONIC MEXICO EG EMPALME Sonora, MX
3015192387 CATHWORKS Newport Beach, CA, US
3004185781 Medtronic, Inc. Tempe, AZ, US
3012520654 MEDTRONIC, INC. Billerica, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K111339 Medtronic, Inc. HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) 2011-06-08
K192492 Astura Medical, LLC EL CAPITAN Anterior Lumber Interbody System 2020-04-21
K212498 Nexus Spine, LLC Stable-L Standalone Lumbar Interbody System 2022-03-18
K041888 Signus Medizintechnik GmbH CURVED PEEK TETRIS SPINAL IMPLANT 2004-08-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2008 N/A 1
EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

Similar Registrations

Registration Number Establishment Name Location
3017936978 CARLSMED, INC. Carlsbad, CA, US
3016050940 Olive Branch Distribution Center Olive Branch, MS, US
3006783837 STRUCTURE MEDICAL, LLC. Naples, FL, US
3011795235 MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH DEGGENDORF Bavaria, DE
1424263 Isomedix Operations, Inc. Libertyville, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005677016. Last updated year: 2026. Please use registration number 3005677016 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.