Klassic Sombrero Patella with E-Link

GUDID 00814703014864

Sombrero Patella with E-Link, size 2, 10mm

TOTAL JOINT ORTHOPEDICS, INC.

Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis

• Primary Device ID: 00814703014864
• NIH Device Record Key: b4c6d938-7ea0-4c03-8bd7-9f57fdfd0ecb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Sombrero Patella with E-Link
• Version Model Number: 5503.02.010
• 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
• Phone: +1(801)486-6070
• Email: udi@tjoinc.com
• Phone: +1(801)486-6070
• Email: udi@tjoinc.com
• Phone: +1(801)486-6070
• Email: udi@tjoinc.com
• Phone: +1(801)486-6070
• Email: udi@tjoinc.com
• Phone: +1(801)486-6070
• Email: udi@tjoinc.com
• Phone: +1(801)486-6070
• Email: udi@tjoinc.com
• Phone: +1(801)486-6070
• Email: udi@tjoinc.com
• Phone: +1(801)486-6070
• Email: udi@tjoinc.com
• Phone: +1(801)486-6070
• Email: udi@tjoinc.com
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814703014864 [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

[00814703014864]

Ethylene Oxide

[00814703014864]

Ethylene Oxide

[00814703014864]

Ethylene Oxide

[00814703014864]

Ethylene Oxide

[00814703014864]

Ethylene Oxide

[00814703014864]

Ethylene Oxide

[00814703014864]

Ethylene Oxide

[00814703014864]

Ethylene Oxide

[00814703014864]

Ethylene Oxide

[00814703014864]

Ethylene Oxide

[00814703014864]

Ethylene Oxide

[00814703014864]

Ethylene Oxide

[00814703014864]

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 Sombrero Patella with E-Link ]

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• 00814703014871: Sombrero Patella with E-Link, size 3, 10mm
• 00814703014864: Sombrero Patella with E-Link, size 2, 10mm
• 00814703014857: Sombrero Patella with E-Link, size 1, 10mm
• 00814703014840: Sombrero Patella with E-Link, size 4, 7mm
• 00814703014833: Sombrero Patella with E-Link, size 3, 7mm
• 00814703014826: Sombrero Patella with E-Link, size 2, 7mm
• 00814703014819: Sombrero Patella with E-Link, size 1, 7mm