Klassic Tibial Augment

GUDID 00810094701000

Tibial Augment, Size 1-2, 5mm

TOTAL JOINT ORTHOPEDICS, INC.

Knee arthroplasty wedge
Primary Device ID00810094701000
NIH Device Record Key65236770-f795-45d1-919d-d91cb124888d
Commercial Distribution StatusIn Commercial Distribution
Brand NameKlassic Tibial Augment
Version Model Number6404.01.005
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

Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810094701000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00810094701000]

Radiation Sterilization


[00810094701000]

Radiation Sterilization


[00810094701000]

Radiation Sterilization


[00810094701000]

Radiation Sterilization


[00810094701000]

Radiation Sterilization


[00810094701000]

Radiation Sterilization


[00810094701000]

Radiation Sterilization


[00810094701000]

Radiation Sterilization


[00810094701000]

Radiation Sterilization


[00810094701000]

Radiation Sterilization


[00810094701000]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-16
Device Publish Date2024-12-06

On-Brand Devices [Klassic Tibial Augment]

00810094701055Tibial Augment, Size 5-6, 10mm
00810094701048Tibial Augment, Size 5-6, 5mm
00810094701031Tibial Augment, Size 3-4, 10mm
00810094701024Tibial Augment, Size 3-4, 5mm
00810094701017Tibial Augment, Size 1-2, 10mm
00810094701000Tibial Augment, Size 1-2, 5mm

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