Klassic Tibial Insert, PS-Max, Std Poly

GUDID 00819251028028

Tibial Insert, PS-Max, Std Poly, Size 2, 14mm

TOTAL JOINT ORTHOPEDICS, INC.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 00819251028028
• NIH Device Record Key: 58040429-d5a1-4a8d-b074-c8287a7d439f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Tibial Insert, PS-Max, Std Poly
• Version Model Number: 6300.02.014
• 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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819251028028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202740

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[00819251028028]

Radiation Sterilization

[00819251028028]

Radiation Sterilization

[00819251028028]

Radiation Sterilization

[00819251028028]

Radiation Sterilization

[00819251028028]

Radiation Sterilization

[00819251028028]

Radiation Sterilization

[00819251028028]

Radiation Sterilization

[00819251028028]

Radiation Sterilization

[00819251028028]

Radiation Sterilization

[00819251028028]

Radiation Sterilization

[00819251028028]

Radiation Sterilization

[00819251028028]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-10
• Device Publish Date: 2020-12-02

On-Brand Devices [Klassic Tibial Insert, PS-Max, Std Poly ]

• 00819251028523: Tibial Insert, PS-Max, Std Poly, Size 6, 24mm
• 00819251028516: Tibial Insert, PS-Max, Std Poly, Size 6, 22mm
• 00819251028509: Tibial Insert, PS-Max, Std Poly, Size 6, 21mm
• 00819251028493: Tibial Insert, PS-Max, Std Poly, Size 6, 20mm
• 00819251028486: Tibial Insert, PS-Max, Std Poly, Size 6, 18mm
• 00819251028479: Tibial Insert, PS-Max, Std Poly, Size 6, 16mm
• 00819251028462: Tibial Insert, PS-Max, Std Poly, Size 6, 14mm
• 00819251028455: Tibial Insert, PS-Max, Std Poly, Size 6, 13mm
• 00819251028448: Tibial Insert, PS-Max, Std Poly, Size 6, 12mm
• 00819251028431: Tibial Insert, PS-Max, Std Poly, Size 6, 11mm
• 00819251028424: Tibial Insert, PS-Max, Std Poly, Size 6, 10mm
• 00819251028417: Tibial Insert, PS-Max, Std Poly, Size 5, 24mm
• 00819251028400: Tibial Insert, PS-Max, Std Poly, Size 5, 22mm
• 00819251028394: Tibial Insert, PS-Max, Std Poly, Size 5, 21mm
• 00819251028387: Tibial Insert, PS-Max, Std Poly, Size 5, 20mm
• 00819251028370: Tibial Insert, PS-Max, Std Poly, Size 5, 18mm
• 00819251028363: Tibial Insert, PS-Max, Std Poly, Size 5, 16mm
• 00819251028356: Tibial Insert, PS-Max, Std Poly, Size 5, 14mm
• 00819251028349: Tibial Insert, PS-Max, Std Poly, Size 5, 13mm
• 00819251028332: Tibial Insert, PS-Max, Std Poly, Size 5, 12mm
• 00819251028325: Tibial Insert, PS-Max, Std Poly, Size 5, 11mm
• 00819251028318: Tibial Insert, PS-Max, Std Poly, Size 5, 10mm
• 00819251028301: Tibial Insert, PS-Max, Std Poly, Size 4, 24mm
• 00819251028295: Tibial Insert, PS-Max, Std Poly, Size 4, 22mm
• 00819251028288: Tibial Insert, PS-Max, Std Poly, Size 4, 21mm
• 00819251028271: Tibial Insert, PS-Max, Std Poly, Size 4, 20mm
• 00819251028264: Tibial Insert, PS-Max, Std Poly, Size 4, 18mm
• 00819251028257: Tibial Insert, PS-Max, Std Poly, Size 4, 16mm
• 00819251028240: Tibial Insert, PS-Max, Std Poly, Size 4, 14mm
• 00819251028233: Tibial Insert, PS-Max, Std Poly, Size 4, 13mm
• 00819251028226: Tibial Insert, PS-Max, Std Poly, Size 4, 12mm
• 00819251028219: Tibial Insert, PS-Max, Std Poly, Size 4, 11mm
• 00819251028202: Tibial Insert, PS-Max, Std Poly, Size 4, 10mm
• 00819251028196: Tibial Insert, PS-Max, Std Poly, Size 3, 24mm
• 00819251028189: Tibial Insert, PS-Max, Std Poly, Size 3, 22mm
• 00819251028172: Tibial Insert, PS-Max, Std Poly, Size 3, 21mm
• 00819251028165: Tibial Insert, PS-Max, Std Poly, Size 3, 20mm
• 00819251028158: Tibial Insert, PS-Max, Std Poly, Size 3, 18mm
• 00819251028141: Tibial Insert, PS-Max, Std Poly, Size 3, 16mm
• 00819251028134: Tibial Insert, PS-Max, Std Poly, Size 3, 14mm
• 00819251028127: Tibial Insert, PS-Max, Std Poly, Size 3, 13mm
• 00819251028110: Tibial Insert, PS-Max, Std Poly, Size 3, 12mm
• 00819251028103: Tibial Insert, PS-Max, Std Poly, Size 3, 11mm
• 00819251028097: Tibial Insert, PS-Max, Std Poly, Size 3, 10mm
• 00819251028080: Tibial Insert, PS-Max, Std Poly, Size 2, 24mm
• 00819251028073: Tibial Insert, PS-Max, Std Poly, Size 2, 22mm
• 00819251028066: Tibial Insert, PS-Max, Std Poly, Size 2, 21mm
• 00819251028059: Tibial Insert, PS-Max, Std Poly, Size 2, 20mm
• 00819251028042: Tibial Insert, PS-Max, Std Poly, Size 2, 18mm
• 00819251028035: Tibial Insert, PS-Max, Std Poly, Size 2, 16mm