FDA Registration
Active
🇺🇸 United States
Provisional Locking Screw
Reg #: 3010057495
·
FEI: 3010057495
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- LH MEDICAL CORPORATION
- Registration Number
- 3010057495
- FEI Number
- 3010057495
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6932 Gettysburg Pike
- City
- Fort Wayne
- State
- IN
- ZIP
- 46804
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120370
Owner / Operator
- Firm Name
- LH Medical Corporation
- Operator Number
- 10042802
- Address
- 6932 Gettysburg Pike
- City
- Fort Wayne
- State
- IN
- Postal Code
- 46804
- Country
- US
- Correspondent
- Ty Carpenter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2017-08-18 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2017-08-18 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2017-08-18 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2017-08-18 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2017-08-18 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2017-08-18 |
Proprietary Names
Provisional Locking Screw
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)