Universal Cone Trial, Size 5, 24°

GUDID 00810094692063

Cone Trial, Size 5, 24 degrees

TOTAL JOINT ORTHOPEDICS, INC.

Knee femur prosthesis trial, reusable
Primary Device ID00810094692063
NIH Device Record Key760ab33f-cb0b-4675-bfc7-2034787c8aef
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Cone Trial, Size 5, 24°
Version Model Number2022.05.024
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

Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
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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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810094692063 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810094692063]

Moist Heat or Steam Sterilization


[00810094692063]

Moist Heat or Steam Sterilization


[00810094692063]

Moist Heat or Steam Sterilization


[00810094692063]

Moist Heat or Steam Sterilization


[00810094692063]

Moist Heat or Steam Sterilization


[00810094692063]

Moist Heat or Steam Sterilization


[00810094692063]

Moist Heat or Steam Sterilization


[00810094692063]

Moist Heat or Steam Sterilization


[00810094692063]

Moist Heat or Steam Sterilization


[00810094692063]

Moist Heat or Steam Sterilization


[00810094692063]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-12
Device Publish Date2024-09-04

Devices Manufactured by TOTAL JOINT ORTHOPEDICS, INC.

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00810094701017 - Klassic Tibial Augment2024-12-16 Tibial Augment, Size 1-2, 10mm
00810094701024 - Klassic Tibial Augment2024-12-16 Tibial Augment, Size 3-4, 5mm
00810094701031 - Klassic Tibial Augment2024-12-16 Tibial Augment, Size 3-4, 10mm
00810094701048 - Klassic Tibial Augment2024-12-16 Tibial Augment, Size 5-6, 5mm
00810094701055 - Klassic Tibial Augment2024-12-16 Tibial Augment, Size 5-6, 10mm
00810094701062 - Klassic Tibial Augment & Screw2024-12-16 Includes: Tibial Augment, Size 1-2, 5mm (00810094701000) and Augment Screw, 5mm (00814703019968)
00810094701079 - Klassic Tibial Augment & Screw2024-12-16 Includes: Tibial Augment, Size 1-2, 10mm (00810094701017) and Augment Screw, 10mm (00814703019975)

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