FDA Registration
Active
🇺🇸 United States
Cruciate Retaining Cemented Knee
Reg #: 1038671
·
FEI: 1038671
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EXACTECH, INC.
- Registration Number
- 1038671
- FEI Number
- 1038671
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2320 N.W. 66TH CT.
- City
- GAINESVILLE
- State
- FL
- ZIP
- 32653
- Country
- US
Regulatory Submissions
- 510(k) Number
- K932690
Owner / Operator
- Firm Name
- EXACTECH, INC.
- Operator Number
- 1038671
- Address
- 2320 N.W. 66TH CT., --
- City
- Gainesville
- State
- FL
- Postal Code
- 32653
- Country
- US
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 | 2008-01-14 |
Proprietary Names
Cruciate Retaining Cemented Knee
Establishment Types
Manufacture Medical Device