Data / Medical devices / China / Changzhou Geasure Medical Apparatus And Instruments Co., Ltd
Changzhou Geasure Medical Apparatus And Instruments Co., Ltd: FDA-registered device maker in Changzhou Jiangsu, China, 4 510(k) clearances
Changzhou Geasure Medical Apparatus And Instruments Co., Ltd is registered with the FDA (registration 3026311512) in Changzhou Jiangsu, China. It lists 25 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 15, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3026311512
- Address
- NO.12 Jinfeng Road, West Taihu Science and Technology Industrial Park, Changzhou Jiangsu, China, 213149
- Owner or operator
- Changzhou Geasure Medical Apparatus and Instruments Co., Ltd (10086983)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 29, 2022
- Registered through
- 2026
- Brand names listed
- 2 Depth Gauge, Awl, ?3.2, Probe,Straight, ?3.5, Probe,Curved, Beale Rod Reducer, Bending Iron for Reconstruction Plates 3.5 and 4.5, Bending Pliers for Plates 2.4 to 4, Bending Pliers for Reconstruction Plates 3.5, Bending/Cutting Pliers, Bone graft funnel and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Awl | HWJ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bender | HXW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Extractor | HWB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Forceps, Wire Holding | HYA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Impactor | HWA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Cranioplasty Material Forming | HBX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pusher, Socket | HXO | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Rasp | HTR | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Reamer | HTO | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Starter, Bone Screw | HWD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wrench | HXC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 15, 2023 | K232394 | Internal Locking Plate and Screw Fixation System | HRS | Substantially Equivalent | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | accessdata.fda.gov |
| June 30, 2023 | K230456 | SGM Femoral Nail System | HSB | Substantially Equivalent | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | accessdata.fda.gov |
| March 3, 2023 | K223776 | PEEK Spinal Infusion Cage | MAX | Substantially Equivalent | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | accessdata.fda.gov |
| October 28, 2022 | K222031 | Spinal Inner Fixation System | NKB | Substantially Equivalent | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Impactor
- All makers of Instrument, Cranioplasty Material Forming
- All makers of Awl
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Bender
Updated December 15, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.