FDA Registration
Active
🇨🇳 China
EBI 5.5 Helical Flange Spinal System
Reg #: 3007923096
·
FEI: 3007923096
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Changzhou Biomet Medical Devices Co., Ltd.
- Registration Number
- 3007923096
- FEI Number
- 3007923096
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 235 Chuangxin Road, EPZ Xinbei District
- City
- Changzhou City Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K061441
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 |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2009-10-08 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2009-10-08 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2009-10-08 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2009-10-08 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2009-10-08 |
Proprietary Names
EBI 5.5 Helical Flange Spinal System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)