FDA Registration
Active
🇺🇸 United States
Novation Splined RDD Femoral Stems
Reg #: 1038671
·
FEI: 1038671
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
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
- K063279
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, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2008-01-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2008-01-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2008-01-15 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2008-01-15 |
Proprietary Names
Novation Splined RDD Femoral Stems
Establishment Types
Manufacture Medical Device