FDA Registration
Active
🇹🇼 Taiwan
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
Reg #: 9681642
·
FEI: 1000395711
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- UNITED ORTHOPEDIC CORP.
- Registration Number
- 9681642
- FEI Number
- 1000395711
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 16, Luke 1st Rd. Luzhu Dist.,
- City
- Kaohsiung
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K032037
Owner / Operator
- Firm Name
- UNITED ORTHOPEDIC CORPORATION
- Operator Number
- 9025838
- Address
- 57 Park Ave. 2, Science Park
- City
- Hsinchu
- State
- TW-HSQ
- Postal Code
- TW NOTA300
- Country
- TW
US Agent
- Business Name
- UOC USA INC.
- Contact Name
- Calvin Lin
- Address
- 15251 Alton Parkway, Suite 100
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 3283366
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-21 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-21 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-21 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-21 |
Proprietary Names
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)