FDA.report

Consensus Hip System

Primary DI
00840286808545
Brand
Consensus Hip System
Company
Shalby Advanced Technologies, Inc.
Model
1703-0-0064
Catalog number
1703-0-0064
Device description
Acetabular Shell, Cementless, PC, 64mm
Published
2022-01-17
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

Related Records

Contact Domains

Product Codes

CodeName
JDLProsthesis, hip, semi-constrained (metal cemented acetabular component)

Product Code Classifications

CodeDeviceSpecialtyClass
JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)Orthopedic3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840286808545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286808545008402868085458402868085450840286808545

GMDN Terms

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

Contacts

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 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 DIBrandCompanyProduct codePublished
00840286808439Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808446Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808453Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808460Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808477Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808484Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808491Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808507Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808514Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808521Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808538Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808552Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808569Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808576Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808583Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808590Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808606Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808613Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808620Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808637Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808644Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808651Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808668Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808675Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808682Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808699Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808705Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286802000Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-15
00840286802017Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-15
00840286802024Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-15