Klassic Stem Extension, Femoral, Cemented

GUDID 00814703019531

Stem Extension, Femoral, Cemented, Size 18, 40mm

TOTAL JOINT ORTHOPEDICS, INC.

Knee femur stem prosthesis
Primary Device ID00814703019531
NIH Device Record Key58dd913e-6202-452e-8220-2b646605e697
Commercial Distribution StatusIn Commercial Distribution
Brand NameKlassic Stem Extension, Femoral, Cemented
Version Model Number6600.18.040
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
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
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
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
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
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
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
GS100814703019531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OIYProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Ethylene Oxide

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

[00814703019531]

Radiation Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-01
Device Publish Date2023-05-24

On-Brand Devices [Klassic Stem Extension, Femoral, Cemented ]

00814703019647Stem Extension, Femoral, Cemented, Size 20, 150mm
00814703019630Stem Extension, Femoral, Cemented, Size 20, 120mm
00814703019623Stem Extension, Femoral, Cemented, Size 20, 100mm
00814703019616Stem Extension, Femoral, Cemented, Size 20, 70mm
00814703019609Stem Extension, Femoral, Cemented, Size 20, 50mm
00814703019593Stem Extension, Femoral, Cemented, Size 20, 40mm
00814703019586Stem Extension, Femoral, Cemented, Size 18, 150mm
00814703019579Stem Extension, Femoral, Cemented, Size 18, 120mm
00814703019562Stem Extension, Femoral, Cemented, Size 18, 100mm
00814703019555Stem Extension, Femoral, Cemented, Size 18, 70mm
00814703019548Stem Extension, Femoral, Cemented, Size 18, 50mm
00814703019531Stem Extension, Femoral, Cemented, Size 18, 40mm
00814703019524Stem Extension, Femoral, Cemented, Size 16, 150mm
00814703019517Stem Extension, Femoral, Cemented, Size 16, 120mm
00814703019500Stem Extension, Femoral, Cemented, Size 16, 100mm
00814703019494Stem Extension, Femoral, Cemented, Size 16, 70mm
00814703019487Stem Extension, Femoral, Cemented, Size 16, 50mm
00814703019470Stem Extension, Femoral, Cemented, Size 16, 40mm
00814703019463Stem Extension, Femoral, Cemented, Size 14, 150mm
00814703019456Stem Extension, Femoral, Cemented, Size 14, 120mm
00814703019449Stem Extension, Femoral, Cemented, Size 14, 100mm
00814703019432Stem Extension, Femoral, Cemented, Size 14, 70mm
00814703019425Stem Extension, Femoral, Cemented, Size 14, 50mm
00814703019418Stem Extension, Femoral, Cemented, Size 14, 40mm
00814703019401Stem Extension, Femoral, Cemented, Size 12, 150mm
00814703019395Stem Extension, Femoral, Cemented, Size 12, 120mm
00814703019388Stem Extension, Femoral, Cemented, Size 12, 100mm
00814703019371Stem Extension, Femoral, Cemented, Size 12, 70mm
00814703019364Stem Extension, Femoral, Cemented, Size 12, 50mm
00814703019357Stem Extension, Femoral, Cemented, Size 12, 40mm
00814703019340Stem Extension, Femoral, Cemented, Size 10, 150mm
00814703019333Stem Extension, Femoral, Cemented, Size 10, 120mm
00814703019326Stem Extension, Femoral, Cemented, Size 10, 100mm
00814703019319Stem Extension, Femoral, Cemented, Size 10, 70mm
00814703019302Stem Extension, Femoral, Cemented, Size 10, 50mm
00814703019296Stem Extension, Femoral, Cemented, Size 10, 40mm
00810094700461Stem Extension, Femoral, Cemented, Size 10, 200mm
00810094700454Stem Extension, Femoral, Cemented, Size 10, 200mm
00810094700447Stem Extension, Femoral, Cemented, Size 10, 200mm
00810094700430Stem Extension, Femoral, Cemented, Size 10, 200mm
00810094700423Stem Extension, Femoral, Cemented, Size 10, 200mm
00810094700416Stem Extension, Femoral, Cemented, Size 10, 200mm
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.