Klassic Tibial Insert, PS-Post, E-Link Poly

GUDID 00814703019272

Tibial Insert, PS-Post, E-Link, Size 6, 21mm

TOTAL JOINT ORTHOPEDICS, INC.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 00814703019272
• NIH Device Record Key: fe5f1a3f-369d-4238-b93c-d0babe7e587f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Tibial Insert, PS-Post, E-Link Poly
• Version Model Number: 5305.06.021
• 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: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814703019272 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232414

FDA Product Code

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

Sterilization

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

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

[00814703019272]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-21
• Device Publish Date: 2023-09-13

On-Brand Devices [Klassic Tibial Insert, PS-Post, E-Link Poly]

• 00814703019289: Tibial Insert, PS-Post, E-Link, Size 6, 24mm
• 00814703019272: Tibial Insert, PS-Post, E-Link, Size 6, 21mm
• 00814703019265: Tibial Insert, PS-Post, E-Link, Size 5, 24mm
• 00814703019258: Tibial Insert, PS-Post, E-Link, Size 5, 21mm
• 00814703019241: Tibial Insert, PS-Post, E-Link, Size 4, 24mm
• 00814703019234: Tibial Insert, PS-Post, E-Link, Size 4, 21mm
• 00814703019227: Tibial Insert, PS-Post, E-Link, Size 3, 24mm
• 00814703019210: Tibial Insert, PS-Post, E-Link, Size 3, 21mm
• 00814703019203: Tibial Insert, PS-Post, E-Link, Size 2, 24mm
• 00814703019197: Tibial Insert, PS-Post, E-Link, Size 2, 21mm
• 00814703019180: Tibial Insert, PS-Post, E-Link, Size 1, 24mm
• 00814703019173: Tibial Insert, PS-Post, E-Link, Size 1, 21mm
• 00814703016622: Tibial Insert, PS-Post, E-Link, Size 6, 18mm
• 00814703016554: Tibial Insert, PS-Post, E-Link, Size 5, 18mm
• 00814703016486: Tibial Insert, PS-Post, E-Link, Size 4, 18mm
• 00814703016417: Tibial Insert, PS-Post, E-Link, Size 3, 18mm
• 00814703016349: Tibial Insert, PS-Post, E-Link, Size 2, 18mm
• 00814703016271: Tibial Insert, PS-Post, E-Link, Size 1, 18mm