FDA Registration
Active
🇺🇸 United States
Alteon Bone Screws
Reg #: 3008658204
·
FEI: 3008658204
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Exactech Sarasota
- Registration Number
- 3008658204
- FEI Number
- 3008658204
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7455 16th Street East, Suite 105
- City
- Sarasota
- State
- FL
- ZIP
- 34243
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141797
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/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2014-08-01 |
Proprietary Names
Alteon Bone Screws
Establishment Types
Manufacture Medical Device