FDA.reportPublic FDA data

Tahoe Uni Knee System

Primary DI
00840286813686
Brand
Tahoe Uni Knee System
Company
Shalby Advanced Technologies, Inc.
Model
2060-0-0512
Catalog number
2060-0-0512
Device description
Tibial Insert, UHMWPE, 5, 12mm
Published
2022-01-28
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
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
00840286813686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286813686008402868136868402868136860840286813686

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
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
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