FDA Registration
Active
🇺🇸 United States
HARWOOD DESIGN, INC.
Reg #: 3003761012
·
FEI: 3003761012
·
Expires 2025
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- HARWOOD DESIGN, INC.
- Registration Number
- 3003761012
- FEI Number
- 3003761012
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1507 Clyde Waite Drive
- City
- Bristol
- State
- PA
- ZIP
- 19007
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091782
Owner / Operator
- Firm Name
- Harwood Design, Inc.
- Operator Number
- 10043110
- Address
- 1507 Clyde Waite Drive
- City
- Bristol
- State
- PA
- Postal Code
- 19007
- Country
- US
- Correspondent
- Adam Cilli
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-29 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-29 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-29 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-01-29 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-29 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)