Klassic Femur with Cobalt 3D

GUDID 00814703016745

Femur with Cobalt 3D, size 5

TOTAL JOINT ORTHOPEDICS, INC.

Coated knee femur prosthesis

• Primary Device ID: 00814703016745
• NIH Device Record Key: c7e64ad5-d742-4b1f-97c2-11cea81da7c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Femur with Cobalt 3D
• Version Model Number: 5106.05.000
• 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: +1(801)486-6070
• Email: udi@tjoinc.com

Device Dimensions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814703016745 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162256

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

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

[00814703016745]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-28

On-Brand Devices [Klassic Femur with Cobalt 3D ]

• 00814703016769: Femur with Cobalt 3D, size 7
• 00814703016752: Femur with Cobalt 3D, size 6
• 00814703016745: Femur with Cobalt 3D, size 5
• 00814703016738: Femur with Cobalt 3D, size 4
• 00814703016721: Femur with Cobalt 3D, size 3
• 00814703016714: Femur with Cobalt 3D, size 2