Home GUDID 00844588020742 CKS - VitalitE
Primary DI 00844588020742
Brand CKS - VitalitE
Company CONSENSUS ORTHOPEDICS, INC.
Model 2144-0-3410
Catalog number 2144-0-3410
Device description Tibial Insert, PCL Substituting, VitalitE
Published 2015-10-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00844588020742 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00844588020742 00844588020742 844588020742 0844588020742
GMDN Terms# Term, Definition table Term Definition Tibial insert An 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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 824905723 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 DI Brand Model Catalog Published 00844588000379 Consensus® Bone Screw 0013-1-6515 0013-1-6515 2015-09-24 00844588000386 Consensus® Bone Screw 0013-1-6520 0013-1-6520 2015-09-24 00844588000393 Consensus® Bone Screw 0013-1-6525 0013-1-6525 2015-09-24 00844588000409 Consensus® Bone Screw 0013-1-6530 0013-1-6530 2015-09-24 00844588000416 Consensus® Bone Screw 0013-1-6535 0013-1-6535 2015-09-24 00844588000423 Consensus® Bone Screw 0013-1-6540 0013-1-6540 2015-09-24 00844588000430 Consensus® Bone Screw 0013-1-6545 0013-1-6545 2015-09-24 00844588000447 Consensus® Bone Screw 0013-1-6550 0013-1-6550 2015-09-24 00844588010262 Consensus® Bone Screw 0013-1-6555 0013-1-6555 2015-09-24 00844588010279 Consensus® Bone Screw 0013-1-6560 0013-1-6560 2015-09-24 00844588010286 Consensus® Bone Screw 0013-1-6565 0013-1-6565 2015-09-24 00844588000010 Consensus® Hip System 0006-0-2801 0006-0-2801 2015-09-24 00844588000027 Consensus® Hip System 0006-0-2802 0006-0-2802 2015-09-24 00844588000034 Consensus® Hip System 0006-0-2803 0006-0-2803 2015-09-24 00844588000041 Consensus® Hip System 0006-0-3201 0006-0-3201 2015-09-24 00844588000058 Consensus® Hip System 0006-0-3202 0006-0-3202 2015-09-24 00844588000065 Consensus® Hip System 0006-0-3203 0006-0-3203 2015-09-24 00844588000072 Consensus® Hip System 0007-1-2201 0007-1-2201 2015-09-24 00844588000089 Consensus® Hip System 0007-1-2202 0007-1-2202 2015-09-24 00844588000096 Consensus® Hip System 0007-1-2203 0007-1-2203 2015-09-24
Other Devices Sharing Product Codes# 
consensusortho.com