Contract manufacturerContract sterilizerSHALBY ADVANCED TECHNOLOGIES, INC. (El Dorado Hills, CA)CaliforniaOrthopedicClass II
SHALBY ADVANCED TECHNOLOGIES, INC.
Contract manufacturer and sterilizer · El Dorado Hills, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3020155054 (openFDA record; or search FDA's registration database)
- FEI number
- 3020155054
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Contract sterilizer
- Owner or operator
- Shalby Advanced Technologies, Inc. (FDA owner/operator no. 10082275)
- Registered address
- 1115 Windfield Way, El Dorado Hills, CA 95762
- Contract listings
- 3 device listings, 5 product codes, first listed Jul 20, 2021
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract manufacturing | Jul 10, 2024 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract sterilization | Jul 10, 2024 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | May 22, 2024 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract sterilization | Jul 20, 2021 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Jul 10, 2024 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract sterilization | Jul 10, 2024 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | May 22, 2024 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract sterilization | Jul 20, 2021 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | Contract manufacturing | May 22, 2024 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | Contract sterilization | Jul 20, 2021 |