Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd.
Registered establishment in Changzhou, Jiangsu, China. 25 device types, 4 clearances.
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Awl, Rasp and 23 other device types. Its earliest product listing with the FDA dates from 2022.
25device types registered with the FDA
4510(k) clearances
Registration
| Registered name | CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3026311512 |
| FEI number | 3026311512 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | NO.12 Jinfeng Road, West Taihu Science and Technology Industrial Park |
| Postal code | 213149 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Awl | Class 1 | Awl, ?3.2, Probe,Straight, ?3.5, Probe,Curved | 2023 | 13 |
| Bender | Class 1 | In-Situ Benders ?5.5,Right, Rod Bender, Bending Pliers for Reconstruction Plates 3.5, Coronal Benders, Left, Bending Iron for Reconstruction Plates 3.5 and 4.5, Plate Bender and 4 more | 2023 | 10 |
| Bit, Drill | Class 1 | Drill Bit 2 mm, Drill Bit 11 mm, Drill Sleeve 7.2, LCP Drill Sleeve 2.7 for Drill Bits 2mm, centering sleeve, Protection Sleeve 11/8 and 20 more | 2023 | 27 |
| Cutter, Wire | Class 1 | Rod Cutter, Guide Wire 2.8 mm, Kirschner wires 1.5, Kirschner wires 2, Kirschner wires 0.8, Guide Wire 3.2 mm | 2023 | 10 |
| Extractor | Class 1 | Distractor, size 7-14 | 2023 | 15 |
| Forceps, Wire Holding | Class 1 | Rod Holder, Plate Holder with Thread, Reduction Forceps, pointed reduction forceps, Beale Rod Reducer, Rod Reducer and 2 more | 2023 | 8 |
| Impactor | Class 1 | impactor | 2023 | 18 |
| Instrument, Cranioplasty Material Forming | Class 1 | Dual Ended Feeler Probe, Sensor,Single Head | 2023 | 1 |
| Instrument, Manual, Surgical, General Use | Class 1 | Tube,7mm, Rod Inserter ?5.5, Tube,14mm | 2023 | 110 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | Class 2 | PEEK Spinal Fusion Cage | 2023 | 14 |
| Orthopedic Manual Surgical Instrument | Class 1 | Bone graft funnel, Trial implant, cup curettes, Combined Hammer 500g, Trocar 4 mm, Slide hammer and 7 more | 2023 | 53 |
| Plate, Fixation, Bone | Class 2 | Internal Locking Plate and Screw Fixation System | 2023 | 22 |
| Pusher, Socket | Class 1 | Rod Pusher ?5.5 | 2023 | 6 |
| Rasp | Class 1 | Rasp, Osteotome | 2023 | 12 |
| Reamer | Class 1 | Opening Reamer 14mm, Shaver, Opening Reamer 13mm | 2023 | 23 |
| Rod, Fixation, Intramedullary And Accessories | Class 2 | SGM Femoral Nail System | 2023 | 17 |
| Rongeur | Class 1 | pituitary rongeur | 2023 | 11 |
| Screw, Fixation, Bone | Class 2 | SGM Femoral Nail System, Internal Locking Plate and Screw Fixation System | 2023 | 31 |
| Screwdriver | Class 1 | Flexible Hex Driver Ball Tip (5mm/8mm) (B), Insertion Handle, Torque Limiter, 0.8Nm, Self-Retaining Set Screw Driver, Ratcheting Handle,Quick Connect, T-Handle Ratcheting ,Quick Connect, Multi Axial Reduction Screwdriver, Extraction Screw for screws 2 and 2.4mm and 24 more | 2023 | 18 |
| Starter, Bone Screw | Class 1 | paddle starter | 2023 | 4 |
| Tap, Bone | Class 1 | rotate cutter 9, rotate cutter 10, rotate cutter 12, rotate cutter 14, rotate cutter 8, rotate cutter 11 and 1 more | 2023 | 12 |
| Tape, Measuring, Rulers And Calipers | Class 1 | 2 Depth Gauge, Measuring Device for Locking Bolt, Direct Measuring Device for Guide Wire, Measuring Credit Card, Depth Gauge for Screws 2.4 to 2.7mm, measuring range up to 40mm, Radiographic Ruler and 3 more | 2023 | 42 |
| Template | Class 1 | Rod Template,200mm, Rod Template,500mm | 2023 | 21 |
| Thoracolumbosacral Pedicle Screw System | Class 2 | Spinal Inner Fixation System | 2022 | 15 |
| Wrench | Class 1 | Pin Wrench 4.5 mm, Rod Rotated Wrench,SW4 | 2023 | 14 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232394 | 2023-12-15 | HRS | Traditional | This company |
| K230456 | 2023-06-30 | HSB | Traditional | This company |
| K223776 | 2023-03-03 | MAX | Traditional | This company |
| K222031 | 2022-10-28 | NKB | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2015 |
|---|---|
| Main products | Orthopedic implants, Trauma plates, Spine implants, Joint implants, Sports medicine devices |
| Certifications | ISO13485, CE, FDA 510k |
| Export markets | United States, Saudi Arabia, Tanzania |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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