Augment Trial, Tibial

GUDID 00810094692582

Augment Trial, Tibial, size 3, 10mm

TOTAL JOINT ORTHOPEDICS, INC.

Knee tibia prosthesis trial, reusable
Primary Device ID00810094692582
NIH Device Record Key03510d3d-3d96-40a6-897e-d83f34cd1242
Commercial Distribution StatusIn Commercial Distribution
Brand NameAugment Trial, Tibial
Version Model Number2902.03.010
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

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

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
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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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810094692582 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810094692582]

Moist Heat or Steam Sterilization


[00810094692582]

Moist Heat or Steam Sterilization


[00810094692582]

Moist Heat or Steam Sterilization


[00810094692582]

Moist Heat or Steam Sterilization


[00810094692582]

Moist Heat or Steam Sterilization


[00810094692582]

Moist Heat or Steam Sterilization


[00810094692582]

Moist Heat or Steam Sterilization


[00810094692582]

Moist Heat or Steam Sterilization


[00810094692582]

Moist Heat or Steam Sterilization


[00810094692582]

Moist Heat or Steam Sterilization


[00810094692582]

Moist Heat or Steam Sterilization


[00810094692582]

Moist Heat or Steam Sterilization


[00810094692582]

Moist Heat or Steam Sterilization


[00810094692582]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-22
Device Publish Date2025-05-14

On-Brand Devices [Augment Trial, Tibial]

00810094692605Augment Trial, Tibial, size 5, 10mm
00810094692599Augment Trial, Tibial, size 5, 5mm
00810094692582Augment Trial, Tibial, size 3, 10mm
00810094692575Augment Trial, Tibial, size 3, 5mm
00810094692568Augment Trial, Tibial, size 1, 10mm
00810094692551Augment Trial, Tibial, size 1, 5mm

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