Klassic Tibial Insert, CR/Congruent, E-Link Poly

GUDID 00814703014307

Tibial Insert, CR/Congruent, E-Link Poly, size 6, 12mm

TOTAL JOINT ORTHOPEDICS, INC.

Tibial insert Tibial insert

• Primary Device ID: 00814703014307
• NIH Device Record Key: 072d5fe5-87fc-4388-ac22-358e0bc7233d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Tibial Insert, CR/Congruent, E-Link Poly
• Version Model Number: 5302.06.012
• 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	00814703014307 [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

[00814703014307]

Ethylene Oxide

[00814703014307]

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, CR/Congruent, E-Link Poly ]

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• 00814703014161: Tibial Insert, CR/Congruent, E-Link Poly, size 4, 12mm
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• 00814703014147: Tibial Insert, CR/Congruent, E-Link Poly, size 4, 10mm
• 00814703014130: Tibial Insert, CR/Congruent, E-Link Poly, size 3, 18mm
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• 00814703014086: Tibial Insert, CR/Congruent, E-Link Poly, size 3, 11mm
• 00814703014079: Tibial Insert, CR/Congruent, E-Link Poly, size 3, 10mm
• 00814703014062: Tibial Insert, CR/Congruent, E-Link Poly, size 2, 18mm
• 00814703014055: Tibial Insert, CR/Congruent, E-Link Poly, size 2, 16mm
• 00814703014048: Tibial Insert, CR/Congruent, E-Link Poly, size 2, 14mm
• 00814703014031: Tibial Insert, CR/Congruent, E-Link Poly, size 2, 13mm
• 00814703014024: Tibial Insert, CR/Congruent, E-Link Poly, size 2, 12mm
• 00814703014017: Tibial Insert, CR/Congruent, E-Link Poly, size 2, 11mm
• 00814703014000: Tibial Insert, CR/Congruent, E-Link Poly, size 2, 10mm
• 00814703013997: Tibial Insert, CR/Congruent, E-Link Poly, size 1, 18mm
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• 00814703013966: Tibial Insert, CR/Congruent, E-Link Poly, size 1, 13mm
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