Consensus Knee System 2810-0-2127

GUDID 00840286845663

Cut Block, 2mm Resection, 1.27mm

Shalby Advanced Technologies, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID00840286845663
NIH Device Record Key260e94a1-de22-4231-a4a9-16b7c7952b5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameConsensus Knee System
Version Model Number2810-0-2127
Catalog Number2810-0-2127
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
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 Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100840286845663 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


[00840286845663]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-28
Device Publish Date2025-05-20

On-Brand Devices [Consensus Knee System]

00840286815444Tibial Insert, PCL Substituting, R, 5-6, 22mm
00840286815437Tibial Insert, PCL Substituting, R, 5-6, 20mm
00840286815420Tibial Insert, PCL Substituting, R, 5-6, 18mm
00840286815413Tibial Insert, PCL Substituting, R, 5-6, 16mm
00840286815406Tibial Insert, PCL Substituting, R, 5-6, 14mm
00840286815390Tibial Insert, PCL Substituting, R, 5-6, 12mm
00840286815383Tibial Insert, PCL Substituting, R, 5-6, 10mm
00840286815376Tibial Insert, PCL Substituting, R, 3-4, 22mm
00840286815369Tibial Insert, PCL Substituting, R, 3-4, 20mm
00840286815352Tibial Insert, PCL Substituting, R, 3-4, 18mm
00840286815345Tibial Insert, PCL Substituting, R, 3-4, 16mm
00840286815338Tibial Insert, PCL Substituting, R, 3-4, 14mm
00840286815321Tibial Insert, PCL Substituting, R, 3-4, 12mm
00840286815314Tibial Insert, PCL Substituting, R, 3-4, 10mm
00840286815307Tibial Insert, PCL Substituting, R, 1-2, 22mm
00840286815291Tibial Insert, PCL Substituting, R, 1-2, 20mm
00840286815284Tibial Insert, PCL Substituting, R, 1-2, 18mm
00840286815277Tibial Insert, PCL Substituting, R, 1-2, 16mm
00840286815260Tibial Insert, PCL Substituting, R, 1-2, 14mm
00840286815253Tibial Insert, PCL Substituting, R, 1-2, 12mm
00840286815246Tibial Insert, PCL Substituting, R, 1-2, 10mm
00840286815239Tibial Insert, PCL Substituting, R, 0, 22mm
00840286815222Tibial Insert, PCL Substituting, R, 0, 20mm
00840286815215Tibial Insert, PCL Substituting, R, 0, 18mm
00840286815208Tibial Insert, PCL Substituting, R, 0, 16mm
00840286815192Tibial Insert, PCL Substituting, R, 0, 14mm
00840286815185Tibial Insert, PCL Substituting, R, 0, 12mm
00840286815178Tibial Insert, PCL Substituting, R, 0, 10mm
00840286815161Tibial Insert, PCL Substituting, R, 5-6, 18mm
00840286815154Tibial Insert, PCL Substituting, R, 5-6, 16mm
00840286815147Tibial Insert, PCL Substituting, R, 5-6, 14mm
00840286815130Tibial Insert, PCL Substituting, R, 5-6, 12mm
00840286815123Tibial Insert, PCL Substituting, R, 5-6, 10mm
00840286815116Tibial Insert, PCL Substituting, R, 3-4, 18mm
00840286815109Tibial Insert, PCL Substituting, R, 3-4, 16mm
00840286815093Tibial Insert, PCL Substituting, R, 3-4, 14mm
00840286815086Tibial Insert, PCL Substituting, R, 3-4, 12mm
00840286815079Tibial Insert, PCL Substituting, R, 3-4, 10mm
00840286815062Tibial Insert, PCL Substituting, R, 1-2, 22mm
00840286815055Tibial Insert, PCL Substituting, R, 1-2, 20mm
00840286815048Tibial Insert, PCL Substituting, R, 1-2, 18mm
00840286815031Tibial Insert, PCL Substituting, R, 1-2, 16mm
00840286815024Tibial Insert, PCL Substituting, R, 1-2, 14mm
00840286815017Tibial Insert, PCL Substituting, R, 1-2, 12mm
00840286815000Tibial Insert, PCL Substituting, R, 1-2, 10mm
00840286814997Tibial Insert, PCL Substituting, L, 5-6, 22mm
00840286814980Tibial Insert, PCL Substituting, L, 5-6, 20mm
00840286814973Tibial Insert, PCL Substituting, L, 5-6, 18mm
00840286814966Tibial Insert, PCL Substituting, L, 5-6, 16mm
00840286814959Tibial Insert, PCL Substituting, L, 5-6, 14mm

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