FDA Registration
Active
🇺🇸 United States
AltiVate Anatomic Shoulder System
Reg #: 1644408
·
FEI: 1000116912
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ENCORE MEDICAL, L.P.
- Registration Number
- 1644408
- FEI Number
- 1000116912
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 9800 METRIC BLVD.
- City
- AUSTIN
- State
- TX
- ZIP
- 78758
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162024
Owner / Operator
- Firm Name
- ENCORE MEDICAL, L.P.
- Operator Number
- 9002203
- Address
- 9800 METRIC BLVD., --
- City
- Austin
- State
- TX
- Postal Code
- 78758
- Country
- US
- Correspondent
- Sherri - Mellingen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2016-12-20 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2016-12-20 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2016-12-20 |
Proprietary Names
AltiVate Anatomic Shoulder System
Establishment Types
Manufacture Medical Device