Revision Tibial Baseplate Sizer and Trial

GUDID 00810094692643

Revision Tibial Baseplate Sizer and Trial, size 4

TOTAL JOINT ORTHOPEDICS, INC.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID00810094692643
NIH Device Record Key60f0d469-9fe6-4c55-a2b7-e21d21eb490f
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevision Tibial Baseplate Sizer and Trial
Version Model Number2903.04.000
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

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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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
GS100810094692643 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810094692643]

Moist Heat or Steam Sterilization


[00810094692643]

Moist Heat or Steam Sterilization


[00810094692643]

Moist Heat or Steam Sterilization


[00810094692643]

Moist Heat or Steam Sterilization


[00810094692643]

Moist Heat or Steam Sterilization


[00810094692643]

Moist Heat or Steam Sterilization


[00810094692643]

Moist Heat or Steam Sterilization


[00810094692643]

Moist Heat or Steam Sterilization


[00810094692643]

Moist Heat or Steam Sterilization


[00810094692643]

Moist Heat or Steam Sterilization


[00810094692643]

Moist Heat or Steam Sterilization


[00810094692643]

Moist Heat or Steam Sterilization


[00810094692643]

Moist Heat or Steam Sterilization


[00810094692643]

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 [Revision Tibial Baseplate Sizer and Trial]

00810094692667Revision Tibial Baseplate Sizer and Trial, size 6
00810094692650Revision Tibial Baseplate Sizer and Trial, size 5
00810094692643Revision Tibial Baseplate Sizer and Trial, size 4
00810094692636Revision Tibial Baseplate Sizer and Trial, size 3
00810094692629Revision Tibial Baseplate Sizer and Trial, size 2
00810094692612Revision Tibial Baseplate Sizer and Trial, size 1

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