Consensus Knee System/Revision Knee System 2943-1-3414

GUDID 00840286843393

CKS, Trial, Tibial Insert, PCL, Substituting, Left, 14mm, Sz 3/4

Shalby Advanced Technologies, Inc.

Knee tibia prosthesis trial, reusable
Primary Device ID00840286843393
NIH Device Record Keydb11a227-4fa5-4eb5-8115-eb5e988ce986
Commercial Distribution StatusIn Commercial Distribution
Brand NameConsensus Knee System/Revision Knee System
Version Model Number2943-1-3414
Catalog Number2943-1-3414
Company DUNS085976260
Company NameShalby Advanced Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100840286843393 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840286843393]

Moist Heat or Steam Sterilization

[00840286843393]

Moist Heat or Steam Sterilization

[00840286843393]

Moist Heat or Steam Sterilization

[00840286843393]

Moist Heat or Steam Sterilization

[00840286843393]

Moist Heat or Steam Sterilization

[00840286843393]

Moist Heat or Steam Sterilization

[00840286843393]

Moist Heat or Steam Sterilization

[00840286843393]

Moist Heat or Steam Sterilization

[00840286843393]

Moist Heat or Steam Sterilization

[00840286843393]

Moist Heat or Steam Sterilization

[00840286843393]

Moist Heat or Steam Sterilization

[00840286843393]

Moist Heat or Steam Sterilization

[00840286843393]

Moist Heat or Steam Sterilization

[00840286843393]

Moist Heat or Steam Sterilization

[00840286843393]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-30
Device Publish Date2025-05-22

On-Brand Devices [Consensus Knee System/Revision Knee System]

00840286855099Femoral/Tibial Impactor Head Small/Large
00840286855082Femoral/Tibial Impactor Head Small/Large
00840286843843CKS, Trial, Tibial Insert, PCL Substituting, Sz 1/2, Right, 10mm
00840286843836CKS, Trial, Tibial Insert, PCL Substituting, Sz 1/2, Right, 12mm
00840286843829CKS, Trial, Tibial Insert, PCL Substituting, Sz 1/2, Right, 14mm
00840286843812CKS, Trial, Tibial Insert, PCL Substituting, Sz 1/2, Right, 16mm
00840286843805CKS, Trial, Tibial Insert, PCL Substituting, Sz 1/2, Right, 18mm
00840286843799CKS, Trial, Tibial Insert, PCL Substituting, Sz 1/2, Right, 20mm
00840286843782CKS, Trial, Tibial Insert, PCL Substituting, Sz 1/2, Right, 22mm
00840286843775CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 10mm
00840286843768CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 12mm
00840286843751CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 14mm
00840286843744CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 16mm
00840286843737CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 18mm
00840286843720CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 20mm
00840286860055Femoral Resection Indicator, Two Side,1mm
00840286855167Fixation Pin, w/Cut-Out, Ø 3.2mm., 4" Long
00840286855150Fixation Pin, w/Cutout, Ø 3.2mm, 3" Long
00840286855143Fixation Pin w/Cutout, Ø 3.2mm, 2" Long
00840286855136Fixation Pin, Tri-Face, Ø 3.2mm, 2" Long
00840286855129Impactor, Tibial/Femoral, All Plastic, Large, Large Handle
00840286855112Impactor, Tibial/Femoral, All Plastic, Small, Large Handle
00840286855105Impactor, Tibial/Femoral, All Plastic, Large, Small Handle
00840286855075Femoral/Tibial Impactor Handle
00840286855068Fixation Pin, Ø 3.2mm, 4" Long
00840286855051Fixation Pin, Ø 3.2mm, 3" Long
00840286855044Fixation Pin, Ø 3.2mm, 2" Long
00840286843713CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 22mm
00840286843706CKS, Trial, Tibial Insert, PCL Substituting, Sz 5/6, Right, 10mm
00840286843690CKS, Trial, Tibial Insert, PCL Substituting, Sz 5/6, Right, 12mm
00840286843683CKS, Trial, Tibial Insert, PCL Substituting, Sz 5/6, Right, 14mm
00840286843676CKS, Trial, Tibial Insert, PCL Substituting, Sz 5/6, Right, 16mm
00840286843669CKS, Trial, Tibial Insert, PCL Substituting, Sz 5/6, Right, 18mm
00840286843652CKS, Trial, Tibial Insert, PCL Substituting, Sz 5/6, Right, 20mm
00840286843645CKS, Trial, Tibial Insert, PCL Substituting, Sz 5/6, Right, 22mm
00840286843508CKS, Trial, Tibial Insert, PCL, Substituting, Sz 5/6, Left, 22mm
00840286843492CKS, Trial, Tibial Insert, PCL, Substituting, Sz 5/6, Left, 20mm
00840286843485CKS, Trial, Tibial Insert, PCL, Substituting, Sz 5/6, Left, 18mm
00840286843478CKS, Trial, Tibial Insert, PCL, Substituting, Sz 5/6, Left, 16mm
00840286843461CKS, Trial, Tibial Insert, PCL, Substituting, Sz 5/6, Left, 14mm
00840286843454CKS, Trial, Tibial Insert, PCL, Substituting, Sz 5/6, Left, 12mm
00840286843447CKS, Trial, Tibial Insert, PCL, Substituting, Sz 5/6, Left, 10mm
00840286843430CKS, Trial, Tibial Insert, PCL, Substituting, Left, 22mm, Sz 3/4
00840286843423CKS, Trial, Tibial Insert, PCL, Substituting, Left, 20mm, Sz 3/4
00840286843416CKS, Trial, Tibial Insert, PCL, Substituting, Left, 18mm, Sz 3/4
00840286843409CKS, Trial, Tibial Insert, PCL, Substituting, Left, 16mm, Sz 3/4
00840286843393CKS, Trial, Tibial Insert, PCL, Substituting, Left, 14mm, Sz 3/4
00840286843386CKS, Trial, Tibial Insert, PCL, Substituting, Left, 12mm, Sz 3/4
00840286843379CKS, Trial, Tibial Insert, PCL, Substituting, Left, 10mm, Sz 3/4
00840286843362CKS, Trial, Tibial Insert, PCL Subsituting, Left, 22mm, Sz 1/2
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