FDA Registration
Active
🇨🇳 China
Medtronic (Changzhou) Medical Devices Technology Co., Ltd
Reg #: 3005677016
·
FEI: 3005677016
·
Expires 2026
Products
53
Proprietary Names
83
Establishment Types
1
Classifications
53
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Registration Details
- Registration Name
- Medtronic (Changzhou) Medical Devices Technology Co., Ltd
- Registration Number
- 3005677016
- FEI Number
- 3005677016
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building #3, 11 ChangJiang North Road, Xinbei District
- City
- Changzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K162680
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2017-02-02 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2005-05-31 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2008-02-01 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2002-11-19 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2011-01-06 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2011-01-06 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2011-01-06 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2011-01-06 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2011-01-06 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2011-01-06 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2017-09-22 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2017-09-22 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2008-02-27 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2010-02-22 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2015-02-03 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2020-10-12 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2011-08-10 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2006-06-29 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-02-03 |
| Probe | HXB | Class 1 | Orthopedic | No | 2006-06-29 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2001-03-30 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2005-03-23 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2014-10-10 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2008-01-31 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 1992-12-12 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1992-12-12 |
| Bender | HXW | Class 1 | Orthopedic | No | 1992-12-12 |
| Wrench | HXC | Class 1 | Orthopedic | No | 1992-12-12 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2005-03-23 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-06-29 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2008-02-05 |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | Class 2 | Neurology | No | 2016-04-28 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2002-11-19 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2010-03-19 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 1992-07-20 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2021-09-09 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 1978-02-15 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 1978-02-15 |
| Template | HWT | Class 1 | Orthopedic | No | 2006-05-17 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 1992-12-12 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2004-08-18 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2005-05-31 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2020-10-06 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2020-10-06 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 1992-12-12 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
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
CD Horizon Spinal System
SOVEREIGN SPINAL SYSTEM
Manual surgical instrument for general use
CD HORIZON Longitude 2 Instruments and Rods
Curette
CD HORIZON® Fenestrated Screw Set
KYPHON Cement Delivery System
KyphX Bone Filler Device
Rasp
DIVERGENCE Anterior Cervical Fusion 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
T2 STRATOSPHERE Expandable Corpectomy System
CD Perc Trauma
SCREWDRIVER
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
Crescent Spinal System Interbody F
Catalyft PL Expandable Interbody System
CAPSTONE-L SPINAL SYSTEM
CD HorizonSpinal System
Anteralign Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments
ARTHROSCOPE
General Instrument
PASS LP Spinal System
CAPSTONE Spinal System
METRx Microscope
Verte-Stack Capstone L
T2 STRATSOPHERE Expandable Corpectomy System
EM ENT Navigated Suction
DIVERGENCE-L" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
Pyramid +4 Anterior Lumbar Plate
dilator, lachrymal
Chisel, Surgical, Manual
, MOTORS
DRILLS
SURGICAL DRIVE SYSTEM
General Instruments
Capstone Control
MULTIPLE (SURGICAL MALLETS)
BONE TAP
TEMPLATE
Medtronic General Instrument
MULTIPLE (ORTHOPEDIC REAMERS)
ROD BENDER
EEA TAID
Guide Pin; Introducer Tool
DRILL GUIDES
GUIDE WIRES (PINS)
LAA Selection Guide
Anatomic Peek
Establishment Types
Manufacture Medical Device