FDA Registration
Active
🇺🇸 United States
MODULAR PROXIMALLY FLUTED HIP STEM
Reg #: 2249615
·
FEI: 3001049282
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- SCT, INC.
- Registration Number
- 2249615
- FEI Number
- 3001049282
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 509 Commerce St
- City
- FRANKLIN LAKES
- State
- NJ
- ZIP
- 07417
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113789
Owner / Operator
- Firm Name
- SCT, INC.
- Operator Number
- 9040558
- Address
- 509 COMMERCE ST., --
- City
- Franklin Lakes
- State
- NJ
- Postal Code
- 07417
- Country
- US
- Correspondent
- DANIEL - TORTORA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2013-03-26 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2013-03-26 |
Proprietary Names
MODULAR PROXIMALLY FLUTED HIP STEM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)