FDA.reportPublic FDA data

Tahoe Uni Knee System

Primary DI
00840286813679
Brand
Tahoe Uni Knee System
Company
Shalby Advanced Technologies, Inc.
Model
2060-0-0511
Catalog number
2060-0-0511
Device description
Tibial Insert, UHMWPE, 5, 11mm
Published
2022-01-28
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
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286813679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286813679008402868136798402868136790840286813679

GMDN Terms#

Term, Definition table
TermDefinition
Tibial insertAn implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

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
07630345711014MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711021MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711038MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711229MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711236MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711243MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711434MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711441MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711458MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711649MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711656MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711663MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711854MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711861MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711878MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712066MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712073MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712080MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712271MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712288MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712295MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712486MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712493MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712509MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752568MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752575MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752582MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752599MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752605MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752667MOTO Partial Knee SystemMedacta International SAHSX2025-08-05