Femoral Trial, PS-Post/Revision, Klassic ONE

GUDID 00819251026406

Femoral Trial, PS-Post/Revision, Size 6

TOTAL JOINT ORTHOPEDICS, INC.

Knee femur prosthesis trial Knee femur prosthesis trial Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable
Primary Device ID00819251026406
NIH Device Record Key0c98c4f3-7155-4e6b-9e29-9b38a144a9a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameFemoral Trial, PS-Post/Revision, Klassic ONE
Version Model Number2164.06.000
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100819251026406 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00819251026406]

Moist Heat or Steam Sterilization


[00819251026406]

Moist Heat or Steam Sterilization


[00819251026406]

Moist Heat or Steam Sterilization


[00819251026406]

Moist Heat or Steam Sterilization


[00819251026406]

Moist Heat or Steam Sterilization


[00819251026406]

Moist Heat or Steam Sterilization


[00819251026406]

Moist Heat or Steam Sterilization


[00819251026406]

Moist Heat or Steam Sterilization


[00819251026406]

Moist Heat or Steam Sterilization


[00819251026406]

Moist Heat or Steam Sterilization


[00819251026406]

Moist Heat or Steam Sterilization


[00819251026406]

Moist Heat or Steam Sterilization


[00819251026406]

Moist Heat or Steam Sterilization


[00819251026406]

Moist Heat or Steam Sterilization


[00819251026406]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-19
Device Publish Date2020-10-09

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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