FDA Registration
Active
🇨🇳 China
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD.
Reg #: 3008749819
·
FEI: 3008749819
·
Expires 2026
Products
11
Proprietary Names
2
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD.
- Registration Number
- 3008749819
- FEI Number
- 3008749819
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Nanyuan East Road, Tangqiao Town
- City
- Zhangjiagang City Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K133840
Owner / Operator
- Firm Name
- Suzhou Kangli Orthopaedics Instrument Co., Ltd.
- Operator Number
- 10047115
- Address
- Nanyuan East Road, Tanggiao Town
- City
- Zhangjiagang City, Suzhou
- State
- Jiangsu
- Postal Code
- 215600
- Country
- CN
- Correspondent
- Jin Hua Huang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2019-05-07 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-05-07 |
| Prosthesis, Toe, Constrained, Polymer | KWH | Class 2 | Orthopedic | No | 2019-11-20 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2026-04-07 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2016-03-13 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2025-01-07 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-07-02 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-07-02 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2019-05-07 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2024-09-11 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2024-12-20 |
Proprietary Names
Kangli Locking Plate System
KangLi pedical screw spinal system
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device