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Sign in to claim this brandSHALBY ADVANCED TECHNOLOGIES, INC.
US
Last updated September 17, 2026
What SHALBY ADVANCED TECHNOLOGIES, INC. makes
Shalby Advanced Technologies, Inc. manufactures metallic and polyethylene components for knee and hip arthroplasty, including uncoated knee tibia prostheses, posterior-stabilized total knee prostheses, tibial inserts, and acetabular liners. Their portfolio also includes reusable trial components for knee and acetabular surgeries, as well as bipolar femoral head outer components for hemiarthroplasty. Specific systems include unicompartmental, revision, and total knee replacements, alongside modular hip prostheses.
The company’s devices are classified under FDA categories Class I, Class II, and Class III, with all products listed in the FDA’s Unique Device Identifier (UDI) database. Their products are intended for use in the United States, where regulatory compliance follows FDA requirements for medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- 1115 Windfield Way, El Dorado Hills, CA, 95762
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3020155054
- DUNS Number
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Catalogue (4950)
Page 95 of 99| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CS2 Acetabular Cup System | 1007-0-2846 | FDA UDI | Class II | Active |
| CKS Plus | 2596-0-6034 | FDA UDI | Class II | Active |
| CKS Plus | 2597-0-4716 | FDA UDI | Class II | Active |
| Duraniom | 2294-0-0003 | FDA UDI | Class II | Active |
| CS2 Acetabular System | 1906-0-3662 | FDA UDI | Class I | Active |
| UniSyn Hip System | 3473-23000-0 | FDA UDI | Class II | Active |
| CKS - VitalitE | 2044-0-5620 | FDA UDI | Class II | Active |
| Revision Knee System | 2461-0-0812 | FDA UDI | Class II | Active |
| Ambition Knee System | 5110-0-0514 | FDA UDI | Class II | Active |
| CKS Plus | 2595-0-4333 | FDA UDI | Class II | Active |
| CKS Plus | 2598-0-6722 | FDA UDI | Class II | Active |
| UniSyn Hip System | 3461-23230-A | FDA UDI | Class II | Active |
| CKS Plus | 2590-0-0005 | FDA UDI | Class II | Active |
| TaperSet™ Reduced Distal Profile | 1213-0-0150 | FDA UDI | Class II | Active |
| Tahoe Uni Knee System | 2060-0-0614 | FDA UDI | Class II | Active |
| CKS Plus | 2598-0-4024 | FDA UDI | Class II | Active |
| Tahoe Unicompartmental Knee System | 3060-0-3414 | FDA UDI | Class I | Active |
| UniSyn Hip System | 4460-10050-A | FDA UDI | Class I | Active |
| UniSyn Hip System | 4410-10040-A | FDA UDI | Class I | Active |
| Ambition Knee System | 5100-0-0516 | FDA UDI | Class II | Active |
| CKS Plus | 2592-0-1001 | FDA UDI | Class II | Active |
| Consensus Knee System/Revision Knee System | 2943-1-1218 | FDA UDI | Class I | Active |
| CKS Plus | 2598-0-6315 | FDA UDI | Class II | Active |
| CKS Plus | 2598-0-4310 | FDA UDI | Class II | Active |
| CKS Plus | 2595-0-4735 | FDA UDI | Class II | Active |
| CKS Plus | 2598-0-4711 | FDA UDI | Class II | Active |
| CKS Plus | 2589-0-1102 | FDA UDI | Class II | Active |
| CKS Plus | 2588-0-1006 | FDA UDI | Class II | Active |
| CS2 Acetabular System | 1800-1-1400 | FDA UDI | Class I | Active |
| Tahoe Unicompartmental Knee System | 3000-0-0071 | FDA UDI | Class I | Active |
| UniSyn Hip System | 3441-13642-0 | FDA UDI | Class II | Active |
| CKS Plus | 2342-0-5610 | FDA UDI | Class II | Active |
| Ambition Knee System | 5110-0-1525 | FDA UDI | Class II | Active |
| CKS Plus | 2344-0-0010 | FDA UDI | Class II | Active |
| Tahoe Uni Knee System | 2060-0-0213 | FDA UDI | Class II | Active |
| CS2 Acetabular Cup System | 1005-0-2244 | FDA UDI | Class II | Active |
| CS2 Acetabular Cup System | 1718-0-0042 | FDA UDI | Class III | Active |
| Revision Knee System | 2980-0-0014 | FDA UDI | Class I | Active |
| Revision Knee System | 2461-0-0810 | FDA UDI | Class II | Active |
| CKS Plus | 2598-0-4316 | FDA UDI | Class II | Active |
| CKS Plus | 2597-0-6311 | FDA UDI | Class II | Active |
| Ambition Knee System | 5110-0-0530 | FDA UDI | Class II | Active |
| TaperSet™ Reduced Distal Profile | 1213-0-0105 | FDA UDI | Class II | Active |
| UniSyn Hip System | 55030-00 | FDA UDI | Class I | Active |
| CKS Plus | 2596-0-4013 | FDA UDI | Class II | Active |
| CS2 Acet. Cup Sys. - VitalitE | 1166-0-2860 | FDA UDI | Class II | Active |
| CKS - VitalitE | 2143-0-0018 | FDA UDI | Class II | Active |
| UniSyn Hip System | 3461-23038-A | FDA UDI | Class II | Active |
| CS2 Acet. Cup Sys. - VitalitE | 1166-0-2864 | FDA UDI | Class II | Active |
| Bipolar Hip System | 1914-0-0055 | FDA UDI | Class I | Active |
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