FDA Registration
Active
🇺🇸 United States
Equinoxe Reverse Shoulder Superior Augment Glenoid Plate
Reg #: 1038671
·
FEI: 1038671
·
Expires 2025
Products
3
Proprietary Names
5
Establishment Types
1
Classifications
3
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
- K110708
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 | 2011-04-12 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2011-04-12 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2011-04-12 |
Proprietary Names
Equinoxe Reverse Shoulder Superior Augment Glenoid Plate
Equinoxe Reverse Shoulder Glenoid Plate
Equinoxe Reverse Shoulder Posterior Augment Glenoid Plate
Equinoxe Reverse Shoulder 38mm and 42mm Glensopheres
Equinoxe Reverse Shoulder Compression Screw
Establishment Types
Manufacture Medical Device