FDA Registration
Active
🇺🇸 United States
Equinoxe Preserve Stem
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
- K162726
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, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2017-02-13 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2017-02-13 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2017-02-13 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2017-02-13 |
Proprietary Names
Equinoxe Preserve Stem
Establishment Types
Manufacture Medical Device