FDA.reportPublic FDA data

Consensus Hip System

Primary DI
00840286800587
Brand
Consensus Hip System
Company
Shalby Advanced Technologies, Inc.
Model
0009-0-0011
Catalog number
0009-0-0011
Device description
Distal Centralizer, 11mm
Published
2022-01-06
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
JDLProsthesis, hip, semi-constrained (metal cemented acetabular component)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)Orthopedic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286800587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286800587008402868005878402868005870840286800587

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated femoral stem prosthesis, one-pieceA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter11Millimeter

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
00840286800570Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800594Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800600Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800617Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800624Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800631Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00840286800648Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-06
00880304498167Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304498174Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304499065Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304499072Taperloc Complete Primary FemoralBiomet Orthopedics, LLCJDL2018-12-19
00880304452732TAPERLOCBiomet Orthopedics, LLCJDL2017-07-28
00880304452749TAPERLOCBiomet Orthopedics, LLCJDL2017-07-28
00880304452756TAPERLOCBiomet Orthopedics, LLCJDL2017-07-28
B27826000025E0ELEOS™ONKOS SURGICAL, INC.JDL2017-04-03
B27826000026E0ELEOS™ONKOS SURGICAL, INC.JDL2017-04-03
00880304652866COMPRESS® DEVICEBiomet Orthopedics, LLCJDL2016-04-01
00880304461604Compress DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461611Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461628Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461635Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461642Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461659Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461666Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461673Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461680Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461697Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461703Compress® DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461765Compress DeviceBiomet Orthopedics, LLCJDL2015-10-24
00880304461772Compress DeviceBiomet Orthopedics, LLCJDL2015-10-24