FDA Registration
Active
🇺🇸 United States
Segmental Revision System (SRS)
Reg #: 3007993775
·
FEI: 3007993775
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Structure Medical, LLC.
- Registration Number
- 3007993775
- FEI Number
- 3007993775
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 111 Cayuga Dr.
- City
- Mooresville
- State
- NC
- ZIP
- 28117
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111746
Owner / Operator
- Firm Name
- Structure Medical, LLC.
- Operator Number
- 10042434
- Address
- 9935 Business Circle
- City
- Naples
- State
- FL
- Postal Code
- 34112
- Country
- US
- Correspondent
- Tejash Naik
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2024-12-09 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2024-12-09 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2024-12-09 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2024-12-09 |
Proprietary Names
Segmental Revision System (SRS)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)