FDA.reportPublic FDA data

CS2 Acet. Cup Sys. - VitalitE

Primary DI
00840286810913
Brand
CS2 Acet. Cup Sys. - VitalitE
Company
Shalby Advanced Technologies, Inc.
Model
1724-0-3660
Catalog number
1724-0-3660
Device description
Acet. Insert, Rimless, VitalitE, 36mm ID, 60mm
Published
2022-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHPSystem, telethermographic (sole diagnostic screen)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHPSystem, Telethermographic (Sole Diagnostic Screen)Obstetrics/Gynecology3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286810913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286810913008402868109138402868109130840286810913

GMDN Terms#

Term, Definition table
TermDefinition
Constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene) and may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(916)355-7100khansen@consensusortho.com

Regulatory Flags#

DUNS number
085976260
Device count
1
DM exempt
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840286841597Consensus Hip System/UniSyn Hip System4410-10020-A4410-10020-A2025-05-22
00840286841962Consensus Hip System1800-0-08401800-0-08402025-05-22
00840286843034Consensus Knee System/Revision Knee System2800-0-07052800-0-07052025-05-22
00840286847162Tahoe Unicompartmental Knee System3000-0-00793000-0-00792025-05-22
00840286847650Tahoe Unicompartmental Knee System3000-0-00733000-0-00732025-05-22
00840286847728Tahoe Unicompartmental Knee System3000-0-00613000-0-00612025-05-22
00840286853897Consensus Hip System1800-0-08451800-0-08452025-05-22
00840286855105Consensus Knee System/Revision Knee System2800-0-07062800-0-07062025-05-22
00840286855112Consensus Knee System/Revision Knee System2800-0-07072800-0-07072025-05-22
00840286855129Consensus Knee System/Revision Knee System2800-0-07082800-0-07082025-05-22
00840286855174CS2 Acetabular System1800-0-15221800-0-15222025-05-22
00840286840958TaperSet Hip System1910-0-00101910-0-00102025-05-21
00840286840996TaperSet Hip System1910-1-00121910-1-00122025-05-21
00840286845182Consensus Knee System2800-0-29502800-0-29502025-05-21
00840286845588Consensus Knee System2800-1-08002800-1-08002025-05-21
00840286840989Revision Knee System/TaperSet Hip System/Consensus Hip System/UniSyn Hip System4410-20070-A4410-20070-A2025-05-14
00840286843959UniSyn Hip System4410-20031-A4410-20031-A2025-05-14
00840286855082Consensus Knee System/Revision Knee System2800-0-07012800-0-07012025-05-14
00840286855099Consensus Knee System/Revision Knee System2800-0-07022800-0-07022025-05-14
00840286855228CS2 Acetabular System1800-0-15281800-0-15282025-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286810371CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810388CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810395CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810401CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810418CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810425CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810432CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810449CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810456CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810463CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810470CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810487CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810494CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810500CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810517CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810524CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810531CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810548CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810555CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810562CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810579CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810586CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810593CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810609CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810616CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810623CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810630CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810647CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810654CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810661CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24