Klassic Knee Tibial Stem Extension, 125mm

GUDID 00814703011504

TOTAL JOINT ORTHOPEDICS, INC.

Knee stem
Primary Device ID00814703011504
NIH Device Record Key4b2c7c85-32a8-4e3a-98ac-6cc2641c2032
Commercial Distribution StatusIn Commercial Distribution
Brand NameKlassic Knee Tibial Stem Extension, 125mm
Version Model Number5600.00.125
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

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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100814703011504 [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

[00814703011504]

Radiation Sterilization


[00814703011504]

Radiation Sterilization


[00814703011504]

Radiation Sterilization


[00814703011504]

Radiation Sterilization


[00814703011504]

Radiation Sterilization


[00814703011504]

Radiation Sterilization


[00814703011504]

Radiation Sterilization


[00814703011504]

Radiation Sterilization


[00814703011504]

Radiation Sterilization


[00814703011504]

Radiation Sterilization


[00814703011504]

Radiation Sterilization


[00814703011504]

Radiation Sterilization


[00814703011504]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-22

Devices Manufactured by TOTAL JOINT ORTHOPEDICS, INC.

00810094691950 - Universal Cone Impactor Head, Size 1, 12°2024-09-16 Cone Impactor Head, Size 1, 12 degrees
00810094691967 - Universa Cone Impactor Head, Size 2, 12°2024-09-16 Cone Impactor Head, Size 2, 12 degrees
00810094691974 - Universal Cone Impactor Head, Size 3, 18°2024-09-16 Cone Impactor Head, Size 3, 18 degrees
00810094691981 - Universal Cone Impactor Head, Size 4, 18°2024-09-16 Cone Impactor Head, Size 4, 18 degrees
00810094691998 - Universal Cone Impactor Head, Size 5, 24°2024-09-16 Cone Impactor Head, Size 5, 24 degrees
00810094692001 - Universal Cone Impactor Head, Size 6, 24°2024-09-16 Cone Impactor Head, Size 6, 24 degrees
00810094692018 - Universal Cone Impactor Head, Size 7, 24°2024-09-16 Cone Impactor Head, Size 7, 24 degrees
00810094692094 - Cone Extractor2024-09-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.