CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD

FDA Device Registration & Listing · Changzhou Jiangsu, CN · Registration 3026311512

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
3026311512
FEI Number
3026311512
Entity Name
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
City/State/Country
Changzhou Jiangsu, CN
Establishment Address
NO.12 Jinfeng Road, West Taihu Science and Technology Industrial Park, Changzhou Jiangsu 213149, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd (Owner Number: 10086983)
Owner / Operator Contact Address
No. 12, Jinfeng Road, West Taihu Science and Technology Industrial Park, Changzhou, CN-JS 213149, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Measuring Credit Card Measuring Device for Locking Bolt Measuring Block 2 Depth Gauge Depth Gauge for Screws 2.4 to 2.7mm, measuring range up to 40mm Depth Gauge for Screws 2.7 to 4mm, measuring range up to 60 mm Radiographic Ruler Direct Measuring Device for Guide Wire Length probe Dual Ended Feeler Probe, Sensor,Single Head Distractor, size 7-14 Spinal Inner Fixation System Awl, ?3.2, Probe,Straight, ?3.5, Probe,Curved paddle starter Rod Rotated Wrench,SW4 Pin Wrench 4.5 mm Rod Pusher ?5.5 Ratcheting Handle,Quick Connect, T-Handle Ratcheting ,Quick Connect, Multi Axial Reduction Screwdriver Torque Limiter, 0.8Nm Extraction Screw for screws 2 and 2.4mm Screwdriver Shaft 3.5, hexagonal Screwdriver, hexagonal with spherical head 10 mm, cannulated Torque Limiter 4N Screw tap HA4.5 Fixed Angle Screwdriver, Crosslink Setscrew Driver,SW3.5 Screwdriver Shaft,hexagonal, small, 2.5mm Handle with Quick Coupling Stardriver Torque-Limiting Handle,12.5N.m Self-Retaining Break-Off Driver Extraction Screw for Screws 3.5mm Multi Axial Screwdriver, Fixed Angle Reduction Screwdriver Torque Limiter, 1.5Nm Self-Retaining Set Screw Driver Dual Ended Plug Starter, T-Handle with Quick Connect Universal Chuck with T-Handle Short Screw driver With Retention Hex (3.5mm) (B) Handle for Torque Limiters 0.4/0.8/1.2Nm hexagonal screwdriver Handle for Torque Limiter Extraction Screw, conical, for Screws 1.5 and 2mm Extraction Screw, conical, for Screws 2.7, 3.5, 4 and 4.5 Screw tap HB 6.5 Insertion Handle torque-limiting screwdriver Screwdriver, hexagonal, large, 3.5 mm Flexible Hex Driver Ball Tip (5mm/8mm) (B) impactor Universal Drill Guide 2.5 to 3.5 LCP Drill Sleeve 2.4 for Drill Bits 1.8mm Drill Bits 1.8mm Drill Bit 3.2 centering sleeve LCP Drill Sleeve 2.7 for Drill Bits 2mm Drill Sleeve 20/17 Universal Drill Guide 2 to 4 Drill Bit 4mm Drill Bit 2.5 mm Drill Sleeve 2 Drill Bit 4.5mm Protection Sleeve 20/17 Drill Bit 11 mm Fixation Sleeve LCP Drill Bit 2.8mm Drill Bit 16.5mm Drill Bit 1.5mm Drill Sleeve 4.2 LCP Drill Sleeve 3.5, for Drill Bits 2.8 mm Drill Bit 4.3 mm Drill Sleeve 8/4 Drill Sleeve 7.2 Drill Bit 2 mm Protection Sleeve 11/8 universal drill Guide 3.2-4.5 Osteotome Rasp Internal Locking Plate and Screw Fixation System SGM Femoral Nail System Rod Template,200mm, Rod Template,500mm Tap,4.5, Tap,5.5, Tap,6.5, Tap,7.5 rotate cutter 14 rotate cutter 8 rotate cutter 11 rotate cutter 10 rotate cutter 12 rotate cutter 9 Beale Rod Reducer plate holding forceps Rod Holder Reduction Forceps Instrument for temporary reduction Plate Holder with Thread pointed reduction forceps Rod Reducer PEEK Spinal Fusion Cage cup curettes Bone graft funnel Slide hammer Trial implant nerve root retractor Trocar 3.2 mm Combined Hammer 500g Distractor 2 Slap hammer Trocar 4 mm Distractor Cage inserter Long insertion handle Rod Cutter Kirschner wires 1.5 Kirschner wires 0.8 Guide Wire 3.2 mm Kirschner wires 2 Guide Wire 2.8 mm

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2023-01-04
HBX Instrument, Cranioplasty Material Forming Neurology Class 1 882.4500 2023-01-04
HWB Extractor Orthopedic Class 1 888.4540 2023-01-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-12-29
HWJ Awl Orthopedic Class 1 888.4540 2023-01-04
HWD Starter, Bone Screw Orthopedic Class 1 888.4540 2023-01-04
HXC Wrench Orthopedic Class 1 888.4540 2023-01-04
HXO Pusher, Socket Orthopedic Class 1 888.4540 2023-01-04
HXX Screwdriver Orthopedic Class 1 888.4540 2023-01-04
HWA Impactor Orthopedic Class 1 888.4540 2023-01-04
HTW Bit, Drill Orthopedic Class 1 888.4540 2023-08-21
HTR Rasp General, Plastic Surgery Class 1 878.4800 2023-01-04
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-12-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-12-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2023-08-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-08-21
HWT Template Orthopedic Class 1 888.4800 2023-01-04
HWX Tap, Bone Orthopedic Class 1 888.4540 2023-01-04
HYA Forceps, Wire Holding General, Plastic Surgery Class 1 878.4800 2023-01-04
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-05-03
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2023-01-04
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2023-01-04

Official Correspondent

Jing Huang

US Agent Details

Bryan Wong Business: PUREVISION AI, INC. (DBA PURE GLOBAL) Email: us-agent@pureglobal.com Phone: (888) 7681688

Related Public Records

Same Entity

Changzhou Geasure Medical Apparatus and Instruments Co., Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13
K140696 Pioneer Surgical Technology, Inc. STREAMLINE TL SPINAL FIXATION SYSTEM 2014-04-10
K141398 Medicrea International SA PASS LP SPINAL SYSTEM 2015-01-09
K160980 Spineology, Inc. Threshold Pedicular Fixation System, Palisade Pedicular Fixation System 2016-05-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026311512. Last updated year: 2026. Please use registration number 3026311512 when referencing this establishment in official correspondence.
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