FDA Registration
Active
🇺🇸 United States
Consensus Knee System VitalitE Tibial Insert and Patellar Components
Reg #: 3020155054
·
FEI: 3020155054
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SHALBY ADVANCED TECHNOLOGIES, INC.
- Registration Number
- 3020155054
- FEI Number
- 3020155054
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1115 Windfield Way
- City
- El Dorado Hills
- State
- CA
- ZIP
- 95762
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133919
Owner / Operator
- Firm Name
- Shalby Advanced Technologies, Inc.
- Operator Number
- 10082275
- Address
- 1115 Windfield Way
- City
- El Dorado Hills
- State
- CA
- Postal Code
- 95762
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2025-04-08 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2025-04-08 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2025-04-08 |
Proprietary Names
Consensus Knee System VitalitE Tibial Insert and Patellar Components
Establishment Types
Manufacture Medical Device