FDA Registration
Active
🇺🇸 United States
iNSitu Total Hip System
Reg #: 1833506
·
FEI: 1832656
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- BIOPRO, INC.
- Registration Number
- 1833506
- FEI Number
- 1832656
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2929 Lapeer Rd
- City
- PORT HURON
- State
- MI
- ZIP
- 48060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220336
Owner / Operator
- Firm Name
- BIOPRO, INC.
- Operator Number
- 9001497
- Address
- 2929 Lapeer Rd., --
- City
- Port Huron
- State
- MI
- Postal Code
- 48060
- Country
- US
- Correspondent
- Kimberly - Light
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2024-06-13 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2024-06-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2024-06-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2024-06-13 |
Proprietary Names
iNSitu Total Hip System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)