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SHALBY 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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LinkedIn
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Facebook
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Email
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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 48 of 99
DeviceModel / ReferenceRegistriesClassStatus
Ckscase3 CKSCASE3
FDA UDI
Class IActive
CKS - VitalitE 2143-0-3410
FDA UDI
Class IIActive
CS2 Hip System 1130-0-0021
FDA UDI
Class IIActive
Ambition Knee System 5110-0-1612
FDA UDI
Class IIActive
Tahoe Unicompartmental Knee System 3000-0-4802
FDA UDI
Class IActive
UniSyn Hip System 4460-10913-A
FDA UDI
Class IActive
Duraniom 2294-0-0001
FDA UDI
Class IIActive
Consensus Knee System 2252-0-0006
FDA UDI
Class IIActive
UniSyn Hip System 4460-20035-A
FDA UDI
Class IActive
CKS Plus 2596-0-6002
FDA UDI
Class IIActive
CKS Plus 2597-0-4003
FDA UDI
Class IIActive
CKS - VitalitE 2143-0-0020
FDA UDI
Class IIActive
Tahoe Uni Knee System 2060-0-0609
FDA UDI
Class IIActive
Consensus Hip System 1020-0-3843
FDA UDI
Class IIActive
Revision Knee System 55024-00
FDA UDI
Class IActive
Consensus Knee System 2762-0-0005
FDA UDI
Class IIActive
Consensus Hip System 1020-0-4242
FDA UDI
Class IIActive
Consensus Knee System 2041-0-5616
FDA UDI
Class IIActive
Consensus MBK System 2162-0-0016
FDA UDI
Class IIActive
CS2 Acetabular System 1730-0-3656
FDA UDI
Class IActive
CS2 Acetabular System 1905-1-0056
FDA UDI
Class IActive
CKS Plus 2595-0-6330
FDA UDI
Class IIActive
Consensus Hip System 1705-0-2658
FDA UDI
Class IIActive
Consensus Knee System 2253-0-0001
FDA UDI
Class IIActive
CKS - VitalitE 2143-0-1218
FDA UDI
Class IIActive
Consensus MBK System 2552-0-0005
FDA UDI
Class IIActive
Consensus Knee System 2800-0-1052
FDA UDI
Class IActive
CS2 Acetabular System 1907-0-2868
FDA UDI
Class IActive
Ambition Knee System 5110-0-1618
FDA UDI
Class IIActive
UniSyn Hip System 3461-43030-0
FDA UDI
Class IIActive
CKS Plus 2596-0-4324
FDA UDI
Class IIActive
CS2 Acetabular System 1727-0-2866
FDA UDI
Class IActive
CS2 Acetabular Cup System 1709-0-0064
FDA UDI
Class IIActive
TaperSet Hip System 1910-1-0090
FDA UDI
Class IActive
Consensus Knee System 2571-0-0003
FDA UDI
Class IIActive
Consensus Hip System 1510-0-0013
FDA UDI
Class IIActive
Consensus Hip System 1020-0-3852
FDA UDI
Class IIActive
UniSyn Hip System 3426-11213-0
FDA UDI
Class IIActive
CKS Plus 2588-0-0005
FDA UDI
Class IIActive
CKS Plus 2591-0-0103
FDA UDI
Class IIActive
CKS Plus 2594-0-1001
FDA UDI
Class IIActive
CKS Plus 2598-0-6700
FDA UDI
Class IIActive
Revision Knee System 2440-0-1056
FDA UDI
Class IIActive
Consensus Knee System 2810-0-1024
FDA UDI
Class IActive
Consensus Hip System 1901-0-0811
FDA UDI
Class IActive
CS2 Acetabular Cup System 1007-0-2850
FDA UDI
Class IIActive
Consensus Knee System 2373-0-0001
FDA UDI
Class IIActive
Tahoe Uni Knee System 2061-0-0512
FDA UDI
Class IIActive
Revision Knee System 2411-0-0001
FDA UDI
Class IIActive
Consensus Hip System 1015-0-5153
FDA UDI
Class IIActive

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