FDA.reportPublic FDA data

CS2 Acetabular Cup System

Primary DI
00840286810180
Brand
CS2 Acetabular Cup System
Company
Shalby Advanced Technologies, Inc.
Model
1716-0-0060
Catalog number
1716-0-0060
Device description
Acetabular Shell, Multi-Hole, Hemi, Cementless, PC, 60mm
Published
2022-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00840286810180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286810180008402868101808402868101800840286810180

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellAn implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

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
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840286855648CS2 Acetabular System1905-1-00421905-1-00422025-09-22
00840286856676CS2 Acetabular System1904-2-28581904-2-28582025-09-22
00840286860024Consensus Knee System2800-0-20232800-0-20232025-07-07
00840286860031Consensus Knee System2800-0-20242800-0-20242025-07-07
00840286860079Consensus Knee System2800-0-20252800-0-20252025-07-07
00840286853132Consensus Knee System2800-0-20142800-0-20142025-06-04
00840286841016Bipolar Hip System55050-0055050-002025-05-22
00840286841023Bipolar Hip System1914-2-00001914-2-00002025-05-22
00840286841030Bipolar Hip System1814-0-42441814-0-42442025-05-22
00840286841047Bipolar Hip System1814-0-45471814-0-45472025-05-22
00840286841054Bipolar Hip System1814-0-48501814-0-48502025-05-22
00840286841061Bipolar Hip System1814-0-51531814-0-51532025-05-22
00840286841078Bipolar Hip System1814-0-54561814-0-54562025-05-22
00840286841085Bipolar Hip System1814-0-57591814-0-57592025-05-22
00840286841092Bipolar Hip System1814-0-60621814-0-60622025-05-22
00840286841108Bipolar Hip System1914-0-00421914-0-00422025-05-22
00840286841115Bipolar Hip System1914-0-00431914-0-00432025-05-22
00840286841122Bipolar Hip System1914-0-00441914-0-00442025-05-22
00840286841139Bipolar Hip System1914-0-00451914-0-00452025-05-22
00840286841146Bipolar Hip System1914-0-00461914-0-00462025-05-22

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