Klassic Knee Femur, Revision

GUDID 00814703015755

Knee Femur, Revision

TOTAL JOINT ORTHOPEDICS, INC.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 00814703015755
• NIH Device Record Key: 5a000372-cbc3-41ff-b2f3-e00aef215e8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Knee Femur, Revision
• Version Model Number: 6100.04.000
• Company DUNS: 078416717
• Company Name: TOTAL JOINT ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com
• Phone: 8014866070
• Email: udi@tjoinc.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814703015755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183596

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

[00814703015755]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-23
• Device Publish Date: 2023-08-15

On-Brand Devices [Klassic Knee Femur, Revision]

• 00814703015786: Knee Femur, Revision
• 00814703015779: Knee Femur, Revision
• 00814703015762: Knee Femur, Revision
• 00814703015755: Knee Femur, Revision
• 00814703015748: Knee Femur, Revision
• 00814703015731: Knee Femur, Revision
• 00814703015724: Knee Femur, Revision