FDA Registration
Active
🇺🇸 United States
PRO-TECH DESIGN & MFG., INC.
Reg #: 2032521
·
FEI: 3003574398
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- PRO-TECH DESIGN & MFG., INC.
- Registration Number
- 2032521
- FEI Number
- 3003574398
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14561 MARQUARDT AVE.
- City
- SANTA FE SPRINGS
- State
- CA
- ZIP
- 90670
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112897
Owner / Operator
- Firm Name
- PRO-TECH Design & Mfg, Inc.
- Operator Number
- 9048910
- Address
- 14561 MARQUARDT AVE., --
- City
- Santa Fe Springs
- State
- CA
- Postal Code
- 90670
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2015-01-20 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2015-01-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2015-01-20 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2015-01-20 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)