FDA Registration
Active
🇺🇸 United States
Shoulder Innovations Total Shoulder Replacement System
Reg #: 3012544635
·
FEI: 3012544635
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- SHOULDER INNOVATIONS, Inc
- Registration Number
- 3012544635
- FEI Number
- 3012544635
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1535 Steele Ave SW, Suite B
- City
- Grand Rapids
- State
- MI
- ZIP
- 49507
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110905
Owner / Operator
- Firm Name
- Shoulder Innovations, Inc
- Operator Number
- 10051976
- Address
- 1535 Steele Ave SW Suite B
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49507
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2016-05-26 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2016-05-26 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2016-05-26 |
Proprietary Names
Shoulder Innovations Total Shoulder Replacement System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device