FDA Registration
Active
🇨🇳 China
Osteotome; Pelvic Instrument Set; Pliers Orthopedic Surgical Instruments
Reg #: 3012697315
·
FEI: 3012697315
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CHANGZHOU XIETONG INDUSTRIES CO., LTD.
- Registration Number
- 3012697315
- FEI Number
- 3012697315
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ROOM 1105, GELIN NO. 107 MISHIHE ROAD, CHANGZHOU, JIANGSU, CHINA
- City
- CHANGZHOU Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- CHANGZHOU XIETONG INDUSTRIES CO., LTD.
- Operator Number
- 10082488
- Address
- ROOM 1105, GELIN NO. 107 MISHIHE ROAD, CHANGZHOU, JIANGSU, CHINA
- City
- CHANGZHOU
- State
- Jiangsu
- Postal Code
- 213000
- Country
- CN
- Correspondent
- DAVID ZHU
US Agent
- Business Name
- Humiss Inc.
- Contact Name
- James St WU
- Address
- 1942 Broadway St., STE 314C, Boulder, CO, 80302, USA
- City
- Boulder
- State
- CO
- ZIP
- 80302
- Country
- US
- [email protected]
- Phone
- 720 7595888
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2021-10-26 |
Proprietary Names
Osteotome; Pelvic Instrument Set; Pliers Orthopedic Surgical Instruments
Large Fragment Instrument Set; Maxillofacial Instruments Set;
Distractor Instrument Set; Elastic Nails Instrument Set; Elbow Forearm Instrument Set;
ACL Instrument Set; AF Instrument Set; Ankle Instrument Set
Reduction Instrument Set; Rib Plate Instrument Set; Rongeur; Saw Bit;
Posterior Cervical Instrument Set; Posterior Cervical Plate Instruments Set;
Fixator Instrument Set; Flexible Instruments Set; Gamma Interlocking Nail Instrument Set
Small/Large Fragment LCP Instrument Set; Spinal Retractor Instruments;
Cable System Instrument Set; Calcaneal Plate Instruments Set; Cannulated Screw Instrument Set;
Endoscope Instruments Set; Femoral Interlocking Nails Instrument Set;
Total Wrist Joint Set; Ulna Osteotomy Instrument Set; Uterine Curette
Micro Surgery Instruments Set; Non-parallel compressor; Non-parallel distractor;
Hip Joint Instrument Set; Humeral Interlocking Nails Instrument Set; Knee Instrument Set;
Anterior Cervical Instrument Set; Anterior Thoracic Lumbar Vertebra Instrument Set
Screw Removal Kit; Small Fragment Instrument Set;
Curette; Dentistry Instruments Set; Depth Gauge; DHS/DCS Instrument Set; Distal Radius System Set;
Spinal Surgery Instruments; Spine System Instrument Set;
Sutur Forceps; Tibia Interlocking Nails Instrument Set;
CENTRAU
Establishment Types
Export Device to the United States But Perform No Other Operation on Device