FDA Registration
Active
🇺🇸 United States
Persona Revision Knee System Stems and Augments
Reg #: 3010057495
·
FEI: 3010057495
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
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
- K191625
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, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-01-05 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2021-01-05 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2021-01-05 |
Proprietary Names
Persona Revision Knee System Stems and Augments
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)