FDA Registration
Active
🇨🇳 China
TRAUMA INTERNAL FIXATION SYSTEMS
Reg #: 3006801265
·
FEI: 3006801265
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Zhejiang Biomet Medical Products Co., Ltd.
- Registration Number
- 3006801265
- FEI Number
- 3006801265
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 980 Shenli Road
- City
- Jinhua Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K111663
Owner / Operator
- Firm Name
- Biomet, Inc.
- Operator Number
- 1825034
- Address
- 56 East Bell Dr., PO Box 587
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
US Agent
- Business Name
- Zimmer Biomet
- Contact Name
- Holly Seppanen
- Address
- 1800 West Center Street
- City
- Warsaw
- State
- IN
- ZIP
- 46580
- Country
- US
- [email protected]
- Phone
- 952 8470494
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2012-06-18 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2012-06-18 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2012-06-18 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2012-06-18 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2012-06-18 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2012-06-18 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2012-06-18 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2012-06-18 |
Proprietary Names
TRAUMA INTERNAL FIXATION SYSTEMS
Establishment Types
Manufacture Medical Device