Klassic Tibial Baseplate, Revision

GUDID 00810094701246

Tibial Baseplate, Revision, Sz 1

TOTAL JOINT ORTHOPEDICS, INC.

Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 00810094701246
• NIH Device Record Key: c5ba6790-4a92-4947-8df8-132b554b050a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Tibial Baseplate, Revision
• Version Model Number: 6200.01.000
• Company DUNS: 078416717
• Company Name: TOTAL JOINT ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 801-486-6070
• Email: kcardall@tjoinc.com
• Phone: 801-486-6070
• Email: kcardall@tjoinc.com
• Phone: 801-486-6070
• Email: kcardall@tjoinc.com
• Phone: 801-486-6070
• Email: kcardall@tjoinc.com
• Phone: 801-486-6070
• Email: kcardall@tjoinc.com
• Phone: 801-486-6070
• Email: kcardall@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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810094701246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243991

FDA Product Code

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

Sterilization

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

[00810094701246]

Radiation Sterilization

[00810094701246]

Radiation Sterilization

[00810094701246]

Radiation Sterilization

[00810094701246]

Radiation Sterilization

[00810094701246]

Radiation Sterilization

[00810094701246]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-15
• Device Publish Date: 2025-05-07

On-Brand Devices [Klassic Tibial Baseplate, Revision]

• 00810094701307: Tibial Baseplate Assembly, Revision, Sz 1 This contains the following implant numbers: 6200.01.0
• 00810094701246: Tibial Baseplate, Revision, Sz 1