FDA Registration
Active
🇺🇸 United States
Shoulder Innovations Total Shoulder Replacement System
Reg #: 1836116
·
FEI: 3002687954
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- REVELATION MEDICAL DEVICES, LLC
- Registration Number
- 1836116
- FEI Number
- 3002687954
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1105 West Auburn Street
- City
- Auburn
- State
- IN
- ZIP
- 46706
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110905
Owner / Operator
- Firm Name
- REVELATION MEDICAL DEVICES LLC
- Operator Number
- 10051413
- Address
- 1105 WEST AUBURN DRIVE
- City
- Auburn
- State
- IN
- Postal Code
- 46706
- 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 | 2023-09-19 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2023-09-19 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2023-09-19 |
Proprietary Names
Shoulder Innovations Total Shoulder Replacement System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)