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

GUDID 00814703014734

Tibial Insert, Ultra-PS, E-Link Poly, size 6, 13mm

TOTAL JOINT ORTHOPEDICS, INC.

Tibial insert

• Primary Device ID: 00814703014734
• NIH Device Record Key: 3027f0f8-8726-4d50-9b1a-82d2dc015e69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Tibial Insert, Ultra-PS, E-Link Poly,
• Version Model Number: 5303.06.013
• 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
• Phone: +1(801)486-6070
• Email: udi@tjoinc.com

Device Dimensions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814703014734 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180159

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

[00814703014734]

Ethylene Oxide

[00814703014734]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-29

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

• 00814703014734: Tibial Insert, Ultra-PS, E-Link Poly, size 6, 13mm
• 00814703014697: Tibial Insert, Ultra-PS, E-Link Poly, size 5, 18mm