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SHALBY ADVANCED TECHNOLOGIES, INC.

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: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3020155054
DUNS Number: —

Catalogue (4950)

Page 75 of 99

Device	Model / Reference	Registries	Class	Status
CS2 Acetabular Cup System	1709-0-0048	FDA UDI	Class II	Active
UniSyn Hip System	3425-12026-0	FDA UDI	Class II	Active
UniSyn Hip System	4460-13042-B	FDA UDI	Class I	Active
UniSyn Hip System	3461-52226-A	FDA UDI	Class II	Active
CKS Plus	2595-0-6331	FDA UDI	Class II	Active
CKS Plus	2590-0-0100	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1005-0-2860	FDA UDI	Class II	Active
Tahoe Unicompartmental Knee System	3060-0-0011	FDA UDI	Class I	Active
CKS Plus	2341-0-1216	FDA UDI	Class II	Active
Tahoe Unicompartmental Knee System	3000-0-0101	FDA UDI	Class I	Active
Ckscasedemo	CKSCASEDEMO	FDA UDI	Class I	Active
CKS Plus	2596-0-4716	FDA UDI	Class II	Active
CKS Plus	2595-0-6711	FDA UDI	Class II	Active
CKS Plus	2597-0-6016	FDA UDI	Class II	Active
CKS Plus - VitalitE	2348-0-1216	FDA UDI	Class II	Active
Consensus Knee System/Revision Knee System/TaperSet Hip System/Consensus Hip Sys	0800-0-1600	FDA UDI	Class I	Active
Consensus Hip System	1800-2-0611	FDA UDI	Class I	Active
UniSyn Hip System	3461-43026-0	FDA UDI	Class II	Active
UniSyn Hip System	3422-11917-0	FDA UDI	Class II	Active
Consensus Knee System	2252-0-0002	FDA UDI	Class II	Active
Consensus Hip System	2800-0-2238	FDA UDI	Class I	Active
CS2 Acet. Cup Sys. - VitalitE	1177-0-2854	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1718-0-0052	FDA UDI	Class III	Active
CS2 Acetabular Cup System	1006-0-2850	FDA UDI	Class II	Active
CS2 Acetabular Cup System	1708-0-0042	FDA UDI	Class II	Active
TaperSet Hip System	1910-1-0185	FDA UDI	Class I	Active
UniSyn Hip System	4462-42634-B	FDA UDI	Class I	Active
UniSyn Hip System	3461-42834-0	FDA UDI	Class II	Active
Consensus Knee System	2272-0-0002	FDA UDI	Class II	Active
Consensus Hip System	1705-0-2258	FDA UDI	Class II	Active
Consensus Hip System	1800-1-0508	FDA UDI	Class I	Active
Consensus Knee System	2810-0-0100	FDA UDI	Class I	Active
Revision Knee System	2983-0-0545	FDA UDI	Class I	Active
Consensus Hip System	1020-0-2254	FDA UDI	Class II	Active
CKS Plus	2597-0-6004	FDA UDI	Class II	Active
Consensus Knee System	2940-0-5612	FDA UDI	Class I	Active
CKS Plus	2594-0-0002	FDA UDI	Class II	Active
Consensus Hip System	0006-0-2803	FDA UDI	Class II	Active
CS2 Acet. Cup Sys. - VitalitE	1177-0-2858	FDA UDI	Class II	Active
Consensus Knee System	2245-0-1212	FDA UDI	Class II	Active
CKS Plus	2595-0-6731	FDA UDI	Class II	Active
Consensus Hip System	1010-3-0009	FDA UDI	Class II	Active
Revision Knee System	2978-1-0001	FDA UDI	Class I	Active
UniSyn Hip System	3441-13034-0	FDA UDI	Class II	Active
CKS Plus	2589-0-1003	FDA UDI	Class II	Active
CKS Plus	2592-0-1101	FDA UDI	Class II	Active
Cs2case1	CS2CASE1	FDA UDI	Class I	Active
Consensus Knee System	2810-0-1027	FDA UDI	Class I	Active
Consensus Knee System with TiNbN	2290-0-0003	FDA UDI	Class II	Active
CKS Plus	2593-0-0104	FDA UDI	Class II	Active

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