Klassic Femur with Aurum

GUDID 00814703017056

Femur with Aurum, size 2

TOTAL JOINT ORTHOPEDICS, INC.

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 00814703017056
• NIH Device Record Key: 14088482-d799-4c51-a50b-4a40af8054cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Femur with Aurum
• Version Model Number: 5104.02.000
• 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: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com
• Phone: 8014866070
• Email: bsiddoway@tjoinc.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814703017056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211602

FDA Product Code

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

Sterilization

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

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

[00814703017056]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-28
• Device Publish Date: 2022-01-20

On-Brand Devices [Klassic Femur with Aurum]

• 00814703017100: Femur with Aurum, size 7
• 00814703017094: Femur with Aurum, size 6
• 00814703017087: Femur with Aurum, size 5
• 00814703017070: Femur with Aurum, size 4
• 00814703017063: Femur with Aurum, size 3
• 00814703017056: Femur with Aurum, size 2
• 00814703017049: Femur with Aurum, size 1