Femoral Trial, PS-Post/Revision, Klassic ONE

GUDID 00819251029254

Femoral Trial, PS-Post/Revision, Size 1

TOTAL JOINT ORTHOPEDICS, INC.

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Primary Device ID00819251029254
NIH Device Record Key4e8d7a2e-f1d0-400a-88a9-22175f6ad287
Commercial Distribution StatusIn Commercial Distribution
Brand NameFemoral Trial, PS-Post/Revision, Klassic ONE
Version Model Number2170.01.000
Company DUNS078416717
Company NameTOTAL JOINT ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100819251029254 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


[00819251029254]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-28
Device Publish Date2021-10-20

On-Brand Devices [Femoral Trial, PS-Post/Revision, Klassic ONE ]

00819251026413Femoral Trial, PS-Post/Revision, KSize 7
00819251026406Femoral Trial, PS-Post/Revision, Size 6
00819251026390Femoral Trial, PS-Post/Revision, Size 5
00819251026383Femoral Trial, PS-Post/Revision, Size 4
00819251026376Femoral Trial, PS-Post/Revision, Size 3
00819251026369Femoral Trial, PS-Post/Revision, Size 2
00819251026352Femoral Trial, PS-Post/Revision, Size 1
00819251029315Femoral Trial, PS-Post/Revision, Size 7
00819251029308Femoral Trial, PS-Post/Revision, Size 6
00819251029292Femoral Trial, PS-Post/Revision, Size 5
00819251029285Femoral Trial, PS-Post/Revision, Size 4
00819251029278Femoral Trial, PS-Post/Revision, Size 3
00819251029261Femoral Trial, PS-Post/Revision, Size 2
00819251029254Femoral Trial, PS-Post/Revision, Size 1

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