FDA Registration
Active
🇺🇸 United States
SIGN Hip Construct (SHC)
Reg #: 3034525
·
FEI: 3003356728
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SIGN Fracture Care International
- Registration Number
- 3034525
- FEI Number
- 3003356728
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 451 Hills St Ste B
- City
- RICHLAND
- State
- WA
- ZIP
- 99354
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152757
Owner / Operator
- Firm Name
- SIGN Fracture Care International
- Operator Number
- 9045925
- Address
- 451 Hills Street, Suite B, --
- City
- Richland
- State
- WA
- Postal Code
- 99354
- Country
- US
- Correspondent
- Robert J Schmitt
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2015-12-15 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2015-12-15 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2015-12-15 |
Proprietary Names
SIGN Hip Construct (SHC)
Establishment Types
Manufacture Medical Device